1 |
NCT03505034 |
Recruiting New |
Intrathecal Transplantation of UC-MSC in Patients With Late Stage of Chronic Spinal Cord Injury |
|
- Drug: Umbilical Cord Mesenchymal Stem Cells
|
Interventional |
Phase 2 |
- Third Affiliated Hospital, Sun Yat-Sen University
- West China Hospital
- Shanghai East Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- ASIA score scale
- IANR-SCIRFS scale
- Electromyogram test
- (and 2 more...)
|
96 |
All |
18 Years to 65 Years (Adult) |
NCT03505034 |
IT-UCMSC-LCSCI |
|
January 1, 2018 |
December 30, 2018 |
December 30, 2018 |
April 23, 2018 |
April 23, 2018 |
|
- The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
|
2 |
NCT03229031 |
Recruiting |
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury |
|
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores
|
100 |
All |
18 Years to 65 Years (Adult) |
NCT03229031 |
ES135-1601 |
|
April 30, 2018 |
December 31, 2022 |
December 31, 2024 |
July 25, 2017 |
April 12, 2018 |
|
- Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan - Far Eastern Memorial Hospital
New Taipei City, Taiwan - Taipei Veterans General Hospital
Taipei, Taiwan
|
3 |
NCT03447509 |
Not yet recruiting |
Grasping Function After Spinal Cord Injury |
|
- Device: iTMS
- Other: Motor Task
- Device: Sham iTMS
- Other: Training
|
Interventional |
Not Applicable |
- VA Office of Research and Development
- University of Miami
|
U.S. Fed / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Changes in amplitude of Motor evoked potential size
- Grip Strength and 9-hole peg test
|
300 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT03447509 |
B2474-R |
|
April 1, 2018 |
April 1, 2022 |
April 1, 2022 |
February 27, 2018 |
February 27, 2018 |
|
- Miami VA Healthcare System, Miami, FL
Miami, Florida, United States
|
4 |
NCT03390140 |
Not yet recruiting |
ReInventing Yourself After SCI: an Intervention to Improve Outcomes After Spinal Cord Injury |
|
- Behavioral: ReInventing Yourself after SCI structured group CBT
- Behavioral: ReInventing Yourself after SCI study-specific workbook
- Behavioral: ReInventing Yourself after SCI YouTube videos
|
Interventional |
Not Applicable |
- Craig Hospital
- University of Michigan
- Kessler Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Moorong Self-Efficacy Scale (MSES) - assessing change over time
- Generalized Self-Efficacy Scale (GSES)- assessing change over time
- Diener Satisfaction with Life Scale (SWLS)- assessing change over time
- (and 4 more...)
|
252 |
All |
18 Years and older (Adult, Senior) |
NCT03390140 |
90DPHF0002-01-00 |
|
April 2018 |
March 2022 |
March 2022 |
January 4, 2018 |
January 4, 2018 |
|
- Craig Hospital
Englewood, Colorado, United States - University of Michigan
Ann Arbor, Michigan, United States - Kessler Foundation
West Orange, New Jersey, United States
|
5 |
NCT02323698 |
Recruiting |
Effects of Caffeine and Low Oxygen Therapy on Leg Function in Human Spinal Cord Injury |
|
- Dietary Supplement: Caffeine
- Other: AIH
- Dietary Supplement: Placebo
|
Interventional |
Phase 1 Phase 2 |
- Spaulding Rehabilitation Hospital
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Foundation Wings For Life
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in overground walking speed
- Change in muscle strength
|
20 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02323698 |
2017P001940b 1R01HD081274 |
|
October 2014 |
May 2020 |
May 2020 |
December 23, 2014 |
December 4, 2017 |
|
- Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, United States
|
6 |
NCT02923817 |
Recruiting |
Clinical Trial Using Bone Marrow-derived Mononuclear Cells for Spinal Cord Injury |
|
- Biological: Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection
|
Interventional |
Phase 2 |
- Da Nang Hospital
- Kitano Hospital
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety profile and adverse effects of the procedure
- Motor function
- Sensory function
- ASIA Impairment Scale
|
30 |
All |
20 Years to 60 Years (Adult) |
NCT02923817 |
DNHSCI124HP |
DNH |
September 2016 |
December 2018 |
June 2019 |
October 5, 2016 |
January 10, 2017 |
|
- Danang Hospital
Danang, Vietnam
|
7 |
NCT03109782 |
Recruiting |
The Austrian Spinal Cord Injury Study |
- Traumatic Spinal Cord Injury
|
|
Observational |
|
- Paracelsus Medical University
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Change in American Spinal Injury Association Impairment Scale (AIS)
- Change in American Spinal Injury Association Motor Score (ASIAMS)
- Change in American Spinal Injury Association Sensory Score (ASIASS)
- (and 6 more...)
|
1000 |
All |
14 Years and older (Child, Adult, Senior) |
NCT03109782 |
ascis1411 |
ASCIS |
December 2012 |
December 2023 |
December 2023 |
April 12, 2017 |
April 17, 2017 |
|
- Hospital Amstetten, Department of Traumatology
Amstetten, Austria - Ordensklinikum Barmherzige Brüder Eisenstadt, Department of Orthopaedic Surgery
Eisenstadt, Austria - Academic Hospital Feldkirch, Department for Trauma Surgery and Sports Traumatology
Feldkirch, Austria - (and 15 more...)
|
8 |
NCT02574572 |
Recruiting |
Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury |
|
- Biological: Autologous mesenchymal cells transplantation
|
Interventional |
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging
- Functional improvement in ASIA (American Spinal Injury Association) grade
- Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force)
- Improvements in sensorial mapping and neuropathic pain
|
10 |
All |
18 Years to 65 Years (Adult) |
NCT02574572 |
SCI-003 |
|
September 6, 2017 |
December 31, 2019 |
June 30, 2020 |
October 14, 2015 |
November 28, 2017 |
|
- Hospital São Rafael
Salvador, Bahia, Brazil
|
9 |
NCT03504826 |
Not yet recruiting New |
Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics |
|
- Device: Hybrid Assistive Limb (HAL)
|
Interventional |
Not Applicable |
- Brooks Rehabilitation
- University of Florida
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 10-Meter Walk Test (10MWT)
- 6-Minute Walk Test (6MWT)
- American Spinal Cord Injury (ASIA) Impairment Scale
- (and 18 more...)
|
24 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03504826 |
2017-02655 |
|
June 2018 |
March 2021 |
August 2021 |
April 20, 2018 |
April 20, 2018 |
|
- Brooks Rehabilitation
Jacksonville, Florida, United States
|
10 |
NCT03410550 |
Not yet recruiting |
Exoskeleton and Spinal Cord Injury |
|
- Device: Exoskeleton Training
|
Interventional |
Phase 2 |
- McGuire Research Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Blood Pressure (mmHg)
- Walking time (minutes)
- Oxygen uptake (l/min)
- (and 6 more...)
|
20 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03410550 |
02375 |
EXTra-SCI |
May 1, 2018 |
December 30, 2019 |
December 30, 2019 |
January 25, 2018 |
March 29, 2018 |
|
- Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
|
11 |
NCT02936453 |
Recruiting |
STIMO: Epidural Electrical Simulation (EES) With Robot-assisted Rehabilitation in Patients With Spinal Cord Injury. |
|
- Procedure: Device implantation
|
Interventional |
Not Applicable |
- Jocelyne Bloch
- Ecole Polytechnique Fédérale de Lausanne
- Centre Hospitalier Universitaire Vaudois
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and Preliminary efficacy: Walking Index for Spinal Cord Injury (WISCI II)
- Safety and Preliminary efficacy: 10-Meter Walk Test (10MWT)
- Safety and Preliminary efficacy: Weight Bearing Capacity (WBC).
- (and 2 more...)
|
8 |
All |
18 Years to 65 Years (Adult) |
NCT02936453 |
STIMO2016 |
STIMO |
July 2016 |
June 2018 |
June 2018 |
October 18, 2016 |
January 23, 2017 |
|
- Centre Hospitalier Universitaire Vaudois
Lausanne, Canton de Vaud, Switzerland
|
12 |
NCT01597518 |
Recruiting |
Riluzole in Spinal Cord Injury Study |
|
- Drug: Riluzole
- Drug: Placebo
|
Interventional |
Phase 2 Phase 3 |
- AOSpine North America Research Network
- AOSpine International
- Christopher Reeve Paralysis Foundation
- (and 2 more...)
|
Other / Industry / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in ISNCSCI Total Motor Score between 180 days and baseline
|
351 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01597518 |
SPN-12-001 |
RISCIS |
August 2013 |
December 2024 |
December 2024 |
May 14, 2012 |
March 12, 2018 |
|
- Barrow Neurological Institute
Phoenix, Arizona, United States - University of Miami
Miami, Florida, United States - Emory University
Atlanta, Georgia, United States - (and 27 more...)
|
13 |
NCT03063333 |
Recruiting |
Long-term Effect of Hypnosis in Spinal Cord Injury Patients |
|
- Other: Coping-oriented hypnosis
- Other: Neutral hypnosis
|
Interventional |
Not Applicable |
- Lone Knudsen, MSc Psych, PhD
- Central Jutland Regional Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Pain intensity
- Coping
- Pain catastrophizing
- (and 4 more...)
|
75 |
All |
18 Years and older (Adult, Senior) |
NCT03063333 |
240929 |
|
May 17, 2017 |
December 31, 2019 |
December 31, 2019 |
February 24, 2017 |
March 1, 2018 |
|
- Spinal Cord Injury Centre of Western Denmark
Viborg, Denmark
|
14 |
NCT03167801 |
Recruiting |
Melatonin Secretion and Sleep Quality in Spinal Cord Injury Patients |
|
|
Observational |
|
- Centre d'Investigation Clinique et Technologique 805
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Urinary 6-sulfatoxy-melatonin (U6SM)
- Sleep quality
- Daytime sleepiness
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT03167801 |
2016-A00605-46 |
MELATETRA |
July 11, 2017 |
January 30, 2018 |
January 30, 2018 |
May 30, 2017 |
January 25, 2018 |
|
- APHP Hôpital Raymond poincaré
Garches, Ile De France, France
|
15 |
NCT02899637 |
Not yet recruiting |
Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury |
|
- Device: Active high-frequency Transcranial Magnetic Stimulation
- Device: Sham high-frequency Transcranial Magnetic Stimulation
|
Interventional |
Not Applicable |
- University of Sao Paulo
- Universidade Estadual da Paraiba
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in motor scores from baseline to three weeks.
- American Spinal Injury Association Impairment Scale (ASIA), Assessment of change in sensory scores from baseline to three weeks.sensory score.
- Fugl-Meyer Scale for Upper and Lower Members, Assessment of change in motor scores from baseline to three weeks.
- Electromyography (lower limbs), Assessment of change in motor function from baseline to three weeks.
|
30 |
All |
18 Years to 60 Years (Adult) |
NCT02899637 |
18753713.0.0000.5187 |
|
October 2016 |
December 2016 |
May 2017 |
September 14, 2016 |
September 14, 2016 |
|
- Universidade Estadual da Paraiba
Campina Grande, Paraiba, Brazil
|
16 |
NCT02115685 |
Recruiting |
Sympathetic-Somatomotor Coupling in Human Spinal Cord Injury |
|
- Other: Treadmill Training
|
Interventional |
Not Applicable |
- Shirley Ryan AbilityLab
- Marquette University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Arterial blood flow
- Graded Treadmill Exercise Test
- Heart rate
- (and 2 more...)
|
40 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02115685 |
R01NS079751 |
|
April 2014 |
March 2018 |
January 2019 |
April 16, 2014 |
December 28, 2016 |
|
- Rehabilitation Institute of Chicago
Chicago, Illinois, United States
|
17 |
NCT01915095 |
Recruiting |
Improving Motor Function After Spinal Cord Injury |
|
- Device: rTMS
- Device: Sham rTMS
- Other: Training
- Other: Motor Task
|
Interventional |
Not Applicable |
- VA Office of Research and Development
- University of Miami
|
U.S. Fed / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- changes in amplitude of motor evoked potential
|
500 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT01915095 |
B0815-R 20151113 |
|
February 11, 2016 |
January 1, 2020 |
February 1, 2021 |
August 2, 2013 |
December 27, 2017 |
|
- Miami VA Healthcare System, Miami, FL
Miami, Florida, United States - VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburg, Florida, United States - VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States
|
18 |
NCT01714349 |
Recruiting |
Nerve Transfer After Spinal Cord Injuries |
|
- Procedure: Nerve Transfer
|
Interventional |
Not Applicable |
- Washington University School of Medicine
- United States Department of Defense
|
Other / U.S. Fed |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in upper motor strength
- Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores
- Change in Short Form 36 (SF-36) scores
- Change in Michigan Hand Questionnaire (MHQ)
|
20 |
All |
18 Years to 65 Years (Adult) |
NCT01714349 |
NTSCI |
|
October 2012 |
October 2019 |
October 2019 |
October 25, 2012 |
November 6, 2017 |
|
- Washington University
Saint Louis, Missouri, United States
|
19 |
NCT02574585 |
Not yet recruiting |
Autologous Mesenchymal Stem Cells Transplantation in Thoracolumbar Chronic and Complete Spinal Cord Injury Spinal Cord Injury |
|
- Biological: Autologous mesenchymal cells transplantation
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with treatment-related adverse events as assessed by magnetic resonance imaging spinal cord injury
- Functional improvement in ASIA (American Spinal Injury Association) grade
- Functional improvement regarding the AIS (ASIA Impairment Scale) scores (light touch, pin prik and motor force)
- Improvements in sensorial mapping and neuropathic pain
|
40 |
All |
18 Years to 65 Years (Adult) |
NCT02574585 |
SCI-005 |
|
December 2019 |
December 2021 |
January 2022 |
October 14, 2015 |
November 28, 2017 |
|
|
20 |
NCT01491789 |
Recruiting |
Virtual Sailing Simulator in Individuals With Spinal Cord Injury |
|
- Device: The VSail-Access simulator
|
Interventional |
Phase 1 Phase 2 |
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- ASIA Exam
- Spinal Cord Injury Quality of Life Questionnaire (SCI QL-23
- Functional Reach Test, Level of Trunk Activation Test
- (and 2 more...)
|
20 |
All |
18 Years to 55 Years (Adult) |
NCT01491789 |
NA_00044093 |
VSail |
May 2011 |
December 2018 |
December 2018 |
December 14, 2011 |
February 20, 2018 |
|
- Kennedy Krieger Institute
Baltimore, Maryland, United States
|
21 |
NCT03137394 |
Recruiting |
Development of a Model of Shoulder Pain Following Spinal Cord Injury |
|
|
Observational |
|
- Drexel University
- University of Maryland
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Musculoskeletal Pain Survey (MPS)-Change over time
- Pectoralis Minor Muscle Length Change over time
- Shoulder Girdle Tissue Integrity Change over time
- (and 6 more...)
|
68 |
All |
18 Years and older (Adult, Senior) |
NCT03137394 |
SC160041 |
|
October 1, 2017 |
October 31, 2019 |
October 31, 2019 |
May 2, 2017 |
December 4, 2017 |
|
- University of Maryland Rehabilitation and Orthopedic Institute
Gwynn Oak, Maryland, United States - Drexel University
Philadelphia, Pennsylvania, United States
|
22 |
NCT02481440 |
Recruiting |
Umbilical Cord Mesenchymal Stem Cells Transplantation to Patients With Spinal Cord Injury |
- Nerve and Spinal Cord Injuries
|
- Biological: Umbilical Cord Mesenchymal Stem Cells
|
Interventional |
Phase 1 Phase 2 |
- Limin Rong
- Third Affiliated Hospital, Sun Yat-Sen University
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Changes in motor and sensory assessment by the ASIA score and International Association of Neural Restoration Spinal Cord Injury Functional Rating Scale(IANR-SCIRFS)
- Number of participants with adverse events
- Changes in electromyogram and electroneurophysiologic test
- (and 4 more...)
|
44 |
All |
18 Years to 65 Years (Adult) |
NCT02481440 |
UC-MSC-SCI |
|
January 2014 |
December 2017 |
December 2018 |
June 25, 2015 |
May 9, 2017 |
|
- the Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
|
23 |
NCT01828203 |
Recruiting |
Minocycline in Acute Spinal Cord Injury (MASC) |
|
- Drug: Minocycline
- Drug: Placebo
- Procedure: Surgical spinal cord decompression
- Procedure: Maintenance of minimum mean arterial pressure (MAP)
|
Interventional |
Phase 3 |
- Rick Hansen Institute
- University of Calgary
- Alberta Paraplegic foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- ASIA Motor Recovery
- ASIA sensory recovery
- Spinal cord Independence measure (SCIM)
- (and 2 more...)
|
248 |
All |
16 Years and older (Child, Adult, Senior) |
NCT01828203 |
RHI-1005 |
|
June 2013 |
June 2018 |
June 2018 |
April 10, 2013 |
October 30, 2014 |
|
- Princess Alexandra Hospital
Brisbane, Queensland, Australia - Foothills Medical Centre
Calgary, Alberta, Canada - University of Alberta & Royal Alexandra Hospitals
Edmonton, Alberta, Canada - (and 4 more...)
|
24 |
NCT02663310 |
Recruiting |
Treatment for Chronic Spinal Cord Injury: Surgery With Rehabilitation vs Rehabilitation |
|
- Procedure: Surgery
- Procedure: Rehabilitation
|
Interventional |
Not Applicable |
- Kunming Tongren Hospital
- Hong Kong Spinal Cord Injury Fund
- China Spinal Cord Injury Network
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Change of Kunming Locomotor Scale in 1 year
- Change of Walking Index for Spinal Cord Injury in 1 year
- Change of Spinal Cord Independence Measure in 1 year
- (and 3 more...)
|
30 |
All |
18 Years to 60 Years (Adult) |
NCT02663310 |
KunmingTH_HZ_001 |
|
July 2015 |
June 2017 |
June 2018 |
January 26, 2016 |
February 4, 2016 |
|
- Kunming Tongren Hospital
Kunming, Yunnan, China
|
25 |
NCT02495545 |
Recruiting |
Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury |
|
- Procedure: CSFD and elevation of MAP
- Procedure: Maintenance of MAP
|
Interventional |
Phase 2 |
- St. Joseph's Hospital and Medical Center, Phoenix
- University of Miami
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in ITP
- Change in International Standards for Classification of Spinal Cord Injury Motor Score (ISNCSCI, formerly ASIA)
- ISNCSCI Grade
- (and 5 more...)
|
60 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02495545 |
PHX 14BN084 |
|
October 2015 |
August 2017 |
December 2017 |
July 13, 2015 |
December 13, 2016 |
|
- University of Alabama School of Medicine Department of Neurosurgery
Birmingham, Alabama, United States - Barrow Neurological Institute St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States - University of Arizona Department of Surgery Division of Neurosurgery
Tucson, Arizona, United States
|
26 |
NCT03505463 |
Not yet recruiting New |
The Neuroinflammatory Response and Biomarkers in Acute Traumatic Spinal Cord Injury |
- Spinal Cord Injury, Acute
|
- Other: Blood samples
- Other: Cerebrospinal fluid sample
- Other: Clinical examination
|
Observational |
|
- University of Aarhus
- Aarhus University Hospital
- Spinal Cord Injury Centre of Western Denmark
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
- Walking Index for Spinal Cord Injury II (WISCI II)
- The Spinal Cord Independence Measure III (SCIM III)
- (and 6 more...)
|
30 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT03505463 |
490-13-3632 |
|
May 1, 2018 |
September 1, 2018 |
September 1, 2019 |
April 23, 2018 |
April 23, 2018 |
|
|
27 |
NCT02009124 |
Recruiting |
Stem Cell Therapy in Spinal Cord Injury |
|
- Biological: Autologous bone marrow mononuclear cell transplantation
|
Interventional |
Phase 2 |
- Neurogen Brain and Spine Institute
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in clinical symptoms of spinal cord injury after 6 months
- Functional independence measure (FIM)
|
500 |
All |
12 Months to 65 Years (Child, Adult) |
NCT02009124 |
NGBSI-03 |
|
August 2012 |
June 2018 |
December 2018 |
December 11, 2013 |
September 14, 2017 |
|
- Neurogen brain and spine institute
Mumbai, Maharashtra, India
|
28 |
NCT03207737 |
Recruiting |
Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury. |
|
- Behavioral: MENTOR + Telehealth
- Behavioral: Telehealth Only
|
Interventional |
Not Applicable |
- University of Alabama at Birmingham
- Lakeshore Foundation
- The Craig H. Neilsen Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Change in Warwick-Edinburgh Mental Well-Being Scale Score reflecting resilience
|
60 |
All |
18 Years to 50 Years (Adult) |
NCT03207737 |
IRB-170123001 |
MENTOR |
September 1, 2017 |
April 2019 |
May 2019 |
July 5, 2017 |
September 13, 2017 |
|
- Lakeshore Foundation
Birmingham, Alabama, United States
|
29 |
NCT03197675 |
Recruiting |
Acupuncture in Spinal Cord Injury Subjects |
|
|
Interventional |
Not Applicable |
- University of Maryland
- United States Department of Defense
|
Other / U.S. Fed |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Compare pain assessments in patients with SCI treated with acupuncture to patients treated per standard of care alone to assess for efficacy and durability of the effect on pain following SCI.
|
100 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03197675 |
HP-00074616 |
|
March 14, 2018 |
December 31, 2022 |
December 31, 2023 |
June 23, 2017 |
April 13, 2018 |
|
- R Adams Cowley Shock Trauma Center, University of Maryland Medical Center
Baltimore, Maryland, United States
|
30 |
NCT02622295 |
Recruiting |
Musculoskeletal Plasticity After Spinal Cord Injury |
|
- Behavioral: Single-session high-frequency active-resisted stance
- Behavioral: Single-session low-frequency active-resisted stance
- Behavioral: High-frequency active-resisted stance training
- Behavioral: Low-frequency active-resisted stance training
|
Interventional |
Not Applicable |
- Richard K Shields
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- University of Iowa
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Acute gene regulation: MSTN
- Acute gene regulation: PGC1-alpha
- Acute gene regulation: PDK4
- (and 10 more...)
|
80 |
All |
21 Years to 60 Years (Adult) |
NCT02622295 |
200412709 R01HD084645 |
|
May 2015 |
January 2020 |
January 2020 |
December 4, 2015 |
November 29, 2017 |
|
- University of Iowa
Iowa City, Iowa, United States
|
31 |
NCT02451683 |
Recruiting |
Corticospinal Function After Spinal Cord Injury |
|
- Other: Electrophysiology Assessment of Time Domain
- Other: Electrophysiology Assessment of Location
- Other: Training with some stimulation
|
Interventional |
Not Applicable |
- University of Miami
- National Institute of Neurological Disorders and Stroke (NINDS)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Upper-limb motor function
- Cortical Neurophysiological Outcome
- Change in Sensorimotor Function
|
300 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT02451683 |
20150069 R01NS090622-01 |
|
April 2015 |
April 2019 |
April 2020 |
May 22, 2015 |
November 8, 2017 |
|
- The Miami Project to Cure Paralysis
Miami, Florida, United States
|
32 |
NCT02232165 |
Recruiting |
Mean Arterial Blood Pressure Treatment for Acute Spinal Cord Injury |
|
- Other: Hypotension avoidance
- Other: Induced hypertension
|
Interventional |
Not Applicable |
- University of Calgary
- Hotchkiss Brain Institute, University of Calgary
- AANS/CNS Section on Disorders of the Spine and Peripheral Nerves
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in ASIA motor score from baseline
- ASIA sensory score
- Proportion of patients achieving a one-grade improvement in ASIA impairment scale (AIS)
- (and 2 more...)
|
100 |
All |
16 Years and older (Child, Adult, Senior) |
NCT02232165 |
E-24927 |
MAPS |
February 2013 |
June 2019 |
June 2019 |
September 5, 2014 |
November 1, 2017 |
|
- University of Texas Health Science Center San Antonio
San Antonio, Texas, United States - University of Calgary, Foothills Medical Centre
Calgary, Alberta, Canada
|
33 |
NCT03053791 |
Recruiting |
Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait |
|
- Procedure: Deep brain stimulation in mesencephalic locomotor region
- Device: Implantation of a Deep brain stimulation system
|
Interventional |
Not Applicable |
- University of Zurich
- Balgrist University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in 6 Minute Walk Test at baseline and 6 months post intervention
- Change in Timed Up and Go test (TUG) towards baseline
- Change in 6 Minute Walk Test towards baseline
- (and 6 more...)
|
5 |
All |
18 Years and older (Adult, Senior) |
NCT03053791 |
SNCTP000000598 |
DBS-SCI |
February 1, 2017 |
April 2019 |
December 2019 |
February 15, 2017 |
February 15, 2017 |
|
- Balgrist University Hospital
Zurich, Switzerland
|
34 |
NCT02701777 |
Recruiting |
Enhancing STDP After Spinal Cord Injury |
|
- Drug: Seromycin
- Device: STDP
- Other: Training
- (and 4 more...)
|
Interventional |
Phase 4 |
- VA Office of Research and Development
- University of Miami
|
U.S. Fed / Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Changes in amplitude of Motor evoked potential size
|
500 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT02701777 |
B1807-R 20151115 |
|
December 15, 2017 |
January 1, 2020 |
January 1, 2021 |
March 8, 2016 |
January 8, 2018 |
|
- Miami VA Healthcare System, Miami, FL
Miami, Florida, United States
|
35 |
NCT03143179 |
Not yet recruiting |
Acute Cardiac Responses to Spinal Cord Injury |
|
|
Observational |
|
- University of British Columbia
- United States Department of Defense
|
Other / U.S. Fed |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- daily resting ejection fraction
- slope of the Starling curve
|
10 |
All |
18 Years to 60 Years (Adult) |
NCT03143179 |
H16-00818 |
|
October 1, 2018 |
October 1, 2020 |
September 30, 2021 |
May 8, 2017 |
May 8, 2017 |
|
|
36 |
NCT03244098 |
Recruiting |
In-Home Adjustment of New Spinal Cord Injury Caregivers |
|
- Behavioral: Transition Assistance Program
|
Interventional |
Not Applicable |
- Virginia Commonwealth University
- Hunter Holmes McGuire VA Medical Center
- The Craig H. Neilsen Foundation
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Zarit Burden Interview - Change from Baseline, at 2 and 4 Months after Discharge
- The Self-Perceived Burden Scale - Patient - Change from Baseline, at 2 and 4 Months after Discharge
- Short Form - VR 12 Health Survey - Change from Baseline, at 2 and 4 Months after Discharge
- (and 19 more...)
|
88 |
All |
18 Years to 89 Years (Adult, Senior) |
NCT03244098 |
HM20009566 439128 |
|
February 9, 2018 |
December 31, 2020 |
December 31, 2020 |
August 9, 2017 |
March 7, 2018 |
|
- Virginia Commonwealth University
Richmond, Virginia, United States
|
37 |
NCT01599455 |
Recruiting |
Baseline Cardiovascular Measurements in Pediatric Spinal Cord Injury |
|
|
Observational |
|
- Shriners Hospitals for Children
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
315 |
All |
up to 18 Years (Child, Adult) |
NCT01599455 |
SHC-SCI-CV |
|
May 2012 |
May 2019 |
May 2022 |
May 16, 2012 |
August 3, 2017 |
|
- Shriners Hospitals for Children - Chicago
Chicago, Illinois, United States
|
38 |
NCT03411720 |
Recruiting |
Whole Body Exercise in Spinal Cord Injury: Effects on Psychosocial Function |
|
|
Interventional |
Not Applicable |
- Spaulding Rehabilitation Hospital
- The Craig H. Neilsen Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Prevention
|
- Depression
- Pain Severity
- Pain Interference
- (and 7 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03411720 |
2017D006049 |
|
February 28, 2018 |
April 29, 2020 |
April 15, 2021 |
January 26, 2018 |
April 18, 2018 |
|
- Spaulding Rehabilitation Network
Cambridge, Massachusetts, United States
|
39 |
NCT03267212 |
Recruiting |
Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury |
|
- Device: Non-invasive ventilation(NIV)
- Device: Sham Non-invasive ventilation(NIV)
- Other: Functional Electrical Stimulation Row Training (FESRT)
|
Interventional |
Not Applicable |
- Spaulding Rehabilitation Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in Peak Aerobic Capacity during FES-row testing
- Change in cardiac output during FES-row testing
- Change in minute ventilation during FES-row testing
- Change in tidal volume during FES-row testing
|
15 |
All |
18 Years to 60 Years (Adult) |
NCT03267212 |
SpauldingRH-2 |
NIV-Ex-CS |
June 14, 2017 |
September 2018 |
September 2019 |
August 30, 2017 |
April 18, 2018 |
|
- Spaulding Hospital Cambridge
Cambridge, Massachusetts, United States
|
40 |
NCT03319225 |
Not yet recruiting |
Examining the Distal Gut Microbiome After Spinal Cord Injury |
|
|
Observational |
|
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Characterize microbiome composition
- Gastrointestinal transit time
- Autonomic state
- Inflammatory state
|
70 |
All |
18 Years and older (Adult, Senior) |
NCT03319225 |
20170526 |
|
April 16, 2018 |
April 16, 2020 |
April 16, 2020 |
October 24, 2017 |
October 24, 2017 |
|
- University of Miami Miller School of Medicine
Miami, Florida, United States
|
41 |
NCT03394560 |
Not yet recruiting |
rTMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury |
|
- Device: High frequency repetitive transcranial magnetic stimulation
- Device: Sham High frequency repetitive transcranial magnetic stimulation
|
Interventional |
Phase 2 |
- Universidade Federal de Pernambuco
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
- Changes on ASIA Impairment Scale (AIS)
- Changes on Spinal cord independence measure (Self-Reported) III (SCIM-III)
- (and 4 more...)
|
20 |
All |
18 Years to 55 Years (Adult) |
NCT03394560 |
rTMS_BWSTT_SCI |
|
January 30, 2018 |
August 30, 2018 |
January 31, 2019 |
January 9, 2018 |
January 9, 2018 |
|
- Applied Neuroscience Laboratory
Recife, Pernambuco, Brazil
|
42 |
NCT03369080 |
Recruiting |
Prospective Survey of Body Mass Index in People With Spinal Cord Injury. |
|
|
Observational |
|
- Rigshospitalet, Denmark
- Metropolitan University College
- Spinal Cord Injury Centre of Western Denmark
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in Body Mass Index
|
100 |
All |
1 Year to 100 Years (Child, Adult, Senior) |
NCT03369080 |
sub project 1 |
|
November 3, 2017 |
December 31, 2018 |
December 31, 2018 |
December 11, 2017 |
December 12, 2017 |
|
- Clinic for Spinal Cord Injuries, Rigshopitalet
Hornbæk, Denmark
|
43 |
NCT02635893 |
Recruiting |
Lower Limb Function After Spinal Cord Injury |
|
- Drug: D-Cycloserine
- Drug: Placebo
- Other: Training
- (and 2 more...)
|
Interventional |
Phase 4 |
- University of Miami
- The Craig H. Neilsen Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Changes in motor evoked potential size
|
257 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT02635893 |
20150605 |
|
October 2015 |
December 2019 |
October 2020 |
December 21, 2015 |
November 8, 2017 |
|
- The Miami Project to Cure Paralysis
Miami, Florida, United States
|
44 |
NCT03139344 |
Recruiting |
Long Duration Activity and Metabolic Control After Spinal Cord Injury |
|
- Other: Low-frequency Exercise
- Other: High-frequency Exercise
|
Interventional |
Not Applicable |
- University of Iowa
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Acute gene regulation: NR4A3
- Acute gene regulation: PGC1-alpha
- Acute gene regulation: ABRA
- (and 9 more...)
|
96 |
All |
18 Years and older (Adult, Senior) |
NCT03139344 |
201503732 R01HD082109 |
|
August 1, 2015 |
April 2020 |
April 2020 |
May 3, 2017 |
May 3, 2017 |
|
- University of Iowa
Iowa City, Iowa, United States
|
45 |
NCT01567605 |
Recruiting |
Bowel Care and Cardiovascular Function After Spinal Cord Injury |
|
- Drug: Lidocaine lubricant
- Other: Placebo lubricant
|
Interventional |
Phase 4 |
- Simon Fraser University
- University of British Columbia
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Blood pressure change during bowel care
- Duration of bowel care routine
- Cardiovascular symptoms during bowel care
- Heart beat abnormalities during bowel care
|
13 |
All |
19 Years to 80 Years (Adult, Senior) |
NCT01567605 |
2011s0593 |
|
March 2012 |
December 2018 |
December 2018 |
March 30, 2012 |
April 18, 2018 |
|
- Simon Fraser University
Burnaby, British Columbia, Canada - International Collaboration on Repair Discoveries
Vancouver, British Columbia, Canada
|
46 |
NCT02562001 |
Recruiting |
Association Between tDCS and Lokomat Training in Patients With Incomplete Spinal Cord Injury |
|
- Device: Outpatient active group
- Device: Outpatient placebo group
- Device: Inpatient active group
- Device: Inpatient placebo group
|
Interventional |
Not Applicable |
- University of Sao Paulo General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- A. Change in the Walk Index for Spinal Cord Injury, WISCI II
- American Spinal Injury Association Impairment Scale - ASIA
- Change in the (Wechsler Adult Intelligence Scale - WASI 2014)
- (and 18 more...)
|
42 |
All |
18 Years to 65 Years (Adult) |
NCT02562001 |
43450715.7.0000.0068_CAAE |
|
November 2015 |
June 2018 |
November 2018 |
September 29, 2015 |
November 27, 2017 |
|
- Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
|
47 |
NCT03457558 |
Recruiting |
Food Security and Perceptions and Barriers to Healthy Eating in Individuals With Spinal Cord Injuries |
|
|
Observational |
|
- Carolinas Healthcare System
|
Other |
- Observational Model: Other
- Time Perspective: Cross-Sectional
|
- Food Security
- Perception Barriers
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT03457558 |
05-17-21E |
|
October 1, 2017 |
December 31, 2020 |
December 31, 2020 |
March 7, 2018 |
March 7, 2018 |
|
- Carolinas Rehabilitation
Charlotte, North Carolina, United States
|
48 |
NCT02749357 |
Recruiting |
Robotic Gait Training in Spinal Cord Injury |
|
- Device: 30 minutes Lokomat
- Device: 60 minutes Lokomat
|
Interventional |
Not Applicable |
- Instituto Nacional de Rehabilitacion
- National Council of Science and Technology, Mexico
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Baseline Gait speed
- Change in gait speed at first training session
- Change in gait speed at second training session
- (and 120 more...)
|
10 |
All |
16 Years and older (Child, Adult, Senior) |
NCT02749357 |
35/15 |
|
May 2016 |
July 2018 |
September 2018 |
April 25, 2016 |
February 28, 2018 |
|
- Instituto Nacional de Rehabilitación
México city, Mexico City, Mexico
|
49 |
NCT03254797 |
Recruiting |
Stepping Training Using External Feedback in Spinal Cord Injury Patients |
|
- Other: Stepping training with feedback
- Other: Stepping training without feedback
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change of walking speed using 10 meter walk test (10MWT)
- Change of walking stability using Timed up and go test [TUGT]
- Change of lower limb muscle strength using Five times sit-to-stand [FTSST]
- Change of walking endurance using 6 minute walk test (6MWT)
|
17 |
All |
18 Years and older (Adult, Senior) |
NCT03254797 |
PHD/0194/2557 |
|
April 20, 2017 |
July 20, 2018 |
July 20, 2019 |
August 21, 2017 |
August 21, 2017 |
|
- Faculty of Associated Medical Science
Khon Kaen, Muang, Thailand
|
50 |
NCT03144830 |
Recruiting |
Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study |
|
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Change from baseline cardiorespiratory status throughout each of the 25 sessions
- Skin integrity
- Falls
- (and 4 more...)
|
10 |
All |
15 Years and older (Child, Adult, Senior) |
NCT03144830 |
EKSO22214 |
|
June 2016 |
December 2017 |
December 2017 |
May 9, 2017 |
May 9, 2017 |
|
- Foothills Medical Centre
Calgary, Alberta, Canada
|