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Stimulation to Enhance Walking Post-SCI

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ClinicalTrials.gov Identifier: NCT03702842
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : September 25, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Brooks Rehabilitation
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE October 9, 2018
First Posted Date  ICMJE October 11, 2018
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • Change in 10-Meter Walk Test (Interventional) [ Time Frame: Baseline; Week 4 ]
    Performance assessment of comfortable and fastest safe walking speed for 10 meters. A reduced time (in seconds) to complete the 10-Meter Walk Test reflects improvement in walking function.
  • Change in Electromyogram (EMG; Immediate) [ Time Frame: Baseline; 1 hour ]
    EMG will be used to assess the neuromuscular activation of the lower extremity muscles. A wireless, 16-channel EMG system will be applied at various key muscle groups on both lower extremities. Greater amplitude or changes in activation timing in the EMG signal will reflect improvement in muscle activation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Change in 6-Minute Walk Test (Interventional) [ Time Frame: Baseline; Week 4 ]
The 6-Minute Walk Test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stimulation to Enhance Walking Post-SCI
Official Title  ICMJE Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotion After Spinal Cord Injury
Brief Summary This study will investigate the effects of transcutaneous direct current stimulation (tsDCS) on walking function in individuals with incomplete spinal cord injury. Following rehabilitation, individuals with ISCI often demonstrate improved walking function, but continue to have serious impairments that limit mobility, community participation and quality of life. Adjuvants to rehabilitation that increase spinal excitation during training may enhance its effectiveness. tsDCS is a non-invasive neuromodulation approach that uses a mild electrical current, applied over the skin of the low back, to alter the membrane potential of spinal neurons. tsDCS will be applied during locomotor training, a well-established rehabilitation strategy that promotes walking recovery. Locomotor training emphasizes repetitive and task-specific practice of coordinated walking, often with therapist assistance or cueing to promote high quality movement patterns. The study team will explore if tsDCS combined with locomotor training increases spinal excitation and thereby improves the effectiveness of walking rehabilitation.
Detailed Description

The purpose of this study is to investigate the effects of transcutaneous direct current stimulation (tsDCS) on locomotor function and rehabilitation outcomes in individuals with incomplete spinal cord injury (ISCI). tsDCS is a mild, non-invasive form of electrical stimulation that can alter spinal cord excitability.

Specific Aim 1 (Cross-sectional): To test the hypothesis that tsDCS applied during walking will improve motor activation in adults with chronic ISCI. A random order, double blind cross-over study will be conducted across two test sessions to compare the immediate effects of two dosages of tsDCS during walking. To assess motor activation, the primary outcome measure will be lower extremity surface electromyography.

Specific Aim 2 (Interventional): To test the hypothesis that tsDCS applied during 16 sessions of locomotor training will improve functional walking outcomes. Participants will be randomized to receive 16 sessions of locomotor training with one of the two tsDCS dosages. The primary outcome is walking function as measured by standardized clinical tests of walking speed and endurance.

To address the aims of the study, the investigators will use a two-part study design. Following phone and in-person screenings and physician approval, individuals will provide informed consent to the study procedures. In the first part, participants will complete two separate testing sessions, presented in random order, that involve up to 30 minutes of tsDCS at one of two dosages levels while walking. The researchers will assess changes in motor activation before and at the end of the period of walking. For the second part, participants will be randomized to receive 16 sessions of locomotor training with one of the two dosages of tsDCS. Before and after the 16-session intervention (i.e., at baseline and post intervention), the study team will assess functional outcomes through standardized tests of walking speed and endurance.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Participants will be randomized to receive either 16 sessions of locomotor training with lower or higher dosage tsDCS, but will be unaware of the stimulation dosage level.
Primary Purpose: Treatment
Condition  ICMJE
  • SCI - Spinal Cord Injury
  • Incomplete Spinal Cord Injury
Intervention  ICMJE
  • Device: Soterix Medical tsDCS stimulator
    tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
  • Other: Locomotor training
    Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
Study Arms  ICMJE
  • Experimental: Immediate effects
    All participants will complete 2 sessions of walking with tsDCS separated by at least 72 hours. The only difference between sessions will be the dosage of stimulation (higher or lower dosage tsDCS using the Soterix Medical tsDCS stimulator). During each session, participants will be asked to walk for up to 30 minutes on a treadmill while the stimulation is delivered. Assessments will be completed before and after the bout of treadmill walking.
    Intervention: Device: Soterix Medical tsDCS stimulator
  • Experimental: Interventional effects: Higher dosage
    After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the higher dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the higher dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
    Interventions:
    • Device: Soterix Medical tsDCS stimulator
    • Other: Locomotor training
  • Active Comparator: Interventional effects: Lower dosage
    After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the lower dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the lower dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
    Interventions:
    • Device: Soterix Medical tsDCS stimulator
    • Other: Locomotor training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Single spinal cord injury (duration >1 year) classified as neurologic level T12 or above based on the International Standards for the Neurologic Classification of Spinal Cord Injury, and classified on the American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS) as 'C' or 'D' motor incomplete
  • Capable of ambulating 10 feet with or without the use of gait devices, braces, or the assistance of one person
  • Medically stable with no acute illness or infection
  • Able to provide informed consent

Exclusion Criteria:

  • Current diagnosis of an additional neurologic condition such as multiple sclerosis, Parkinson's disease, stroke, or brain injury
  • Presence of unstable or uncontrolled medical conditions such as cardiovascular disease, myocardial infarction (<1 year), pulmonary infection or illness, renal disease, autonomic dysreflexia, infections, pain, heterotopic ossification
  • Cognitive or communication impairments limiting communication with study staff or ability to provide informed consent
  • Lower extremity joint contractures limiting the ability to stand upright and practice walking
  • Skin lesions or wounds affecting participation in walking rehabilitation
  • Acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking rehabilitation
  • Severe spasticity or uncontrolled movements limiting participation in walking rehabilitation
  • Body weight or height that is incompatible with safe use of a support harness and body weight support system
  • Pain that limits walking or participation in walking rehabilitation
  • Current participation in rehabilitation to address walking function
  • Botox injections in lower extremity muscles affecting walking function within 4 months of study enrollment
  • Legal blindness or severe visual impairment
  • Known pregnancy
  • Implanted metal hardware below the level of the 8th thoracic vertebrae
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emily Fox, PT, PhD 352-273-6117 ejfox@phhp.ufl.edu
Contact: Lou DeMark, PT, DPT 904-345-8969 Brooks.Research@BrooksRehab.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03702842
Other Study ID Numbers  ICMJE IRB201801582 -N -A
NIH/NICHD 5P2CHD08685 ( Other Grant/Funding Number: REACT Center Pilot Studies Program )
OCR16206 ( Other Identifier: UF ID )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Brooks Rehabilitation
Investigators  ICMJE
Principal Investigator: Emily Fox, PT, PhD University of Florida
PRS Account University of Florida
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP