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Nerve Transfer After Spinal Cord Injury- Multi-center

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04023591
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : March 22, 2023
Sponsor:
Collaborators:
Stanford University
University of Pennsylvania
University of Michigan
University of Calgary
University of Utah
United States Department of Defense
The Methodist Hospital Research Institute
University of Miami
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like and long-term functional independence will provide a significant public health impact. Specific aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and quality of life and functional independence.

Condition or disease Intervention/treatment
Tetraplegia Spinal Cord Injuries Quadriplegia Flaccid Procedure: Surgery/Occupational Therapy

Detailed Description:

Study Design and Feasibility: A prospective multi-institutional non-randomized single arm design will be utilized. Seventy subjects with cervical ASIA A-B (International Standards for Neurological Classification of Spinal Cord Injury) SCI and hand function impairment that fit the International Classification for Surgery of the Hand 0-4 will be identified. Only patients with stable ASIA scores and no evidence of functional improvement in motor or sensory examination for at least 3 months will be recruited. All patients will undergo Electromyography (EMG) and nerve conduction studies (NCS) to verify intact innervation (normal compound muscle action potentials (CMAPs)) to the paralyzed target muscles below the level of injury. Functional electrical stimulation (FES) will be used to verify loss of lower motor neuron function in key muscle groups in the zone of injury and help differentiate those muscle with intact connections to preserve anterior horn cells. Only those patients with clinically normal, Medical Research Council (MRC) muscle grade 5/5 donor (axonal donor) function will be enrolled.

Outcome Measures Primary Outcome Measures: Pre- and Post-operative upper motor strength. (Manual motor testing & Hand Held Dynamometry) Secondary Outcome Measures: Disabilities of the Arm, Shoulder, and Hand (DASH), Michigan Hand Questionnaire (MHQ), Spinal Cord Injury Quality of Life (SCIQOL), GRASSP test (pre-operative, post-operatively - 6 months, 12 months, and 24 months, 36 months and 48 months), rates of intraoperative and post-operative complications, and rates of reoperation.

Rehabilitation and hand therapy are critical components of motor re-education following nerve transfers. Cortical plasticity and motor remapping occurs following nerve transfers allowing independent functional control of the recipient muscles. All patients will begin rehabilitation and hand therapy beginning 2 weeks after surgery. They undergo one hour of hand therapy and occupational therapy for motor re-education once to twice a week for 48 months following surgery. Rehabilitation will be phased to early and late - added exercises focusing on co-contraction, repetition, and range of motion will be included as home therapy.

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients
Actual Study Start Date : April 13, 2020
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Surgery
Surgery/ Occupational Therapy
 Procedure: Surgery/Occupational Therapy
Surgery based on function and injury/ Occupational therapy for 48 months post-surgery


Outcome Measures
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Primary Outcome Measures :
  1. Manual Motor Testing [ Time Frame: 48 months ]
    Change from baseline testing strength of upper extremities at 48 months post-operatively

  2. Handheld Dynamometry [ Time Frame: 48 months ]
    Change from baseline grip strength at 48 months post-operatively


Secondary Outcome Measures :
  1. Change in Disabilities of Arm, Shoulder and Hand (DASH) scores [ Time Frame: 48 months ]
    Change from baseline DASH scores at 48 months post-operatively. Scores range from 0-100 with 0 being the most positive score representing no arm, shoulder or hand disability and 100 being the lowest score indicating the most severe arm, shoulder and hand disability.

  2. Change in Spinal Cord Injury Quality of Life (SCIQOL) scores [ Time Frame: 48 months ]
    Change in baseline SCIQOL scores at 48 months post-operatively. Five scores of 0-30 (0=less satisfied and 30=most satisfied) are calculated: 1. Total Quality of Life; 2. Health and Functioning Subscale; 3. Social and Economic Subscale; 4. Psychological/Spiritual Subscale; 5 Family Subscale. Calculation of scores weighs satisfaction scores according to level of importance assigned to each item. An overall score can be obtained by summing the scores for all six scales after reversing the pain scale and dividing by six.

  3. Rates of Intra-operative and post-operative complications [ Time Frame: 48 months ]
    The number of complications within and after the operation

  4. Hand Function, measured by the GRASSP test [ Time Frame: 48 months ]
    Change in baseline GRASSP Test results for hand function at 48 months post-operatively

  5. Changes in the Graded Redefined Assessment of Strength, Sensation and Prehension scores (GRASSP) [ Time Frame: 48 months ]
    Change in baseline GRASSP results for strength, sensation and prehension at 48 months post-operatively. Five subtests: 1. Dorsal sensation (3 locations) each scored 0-4 (sum =subtest score, 0-12, with 0 being no sensation and 12 being normal sensation); 2. Palmar sensation (same as above); 3. Strength (10 muscles of arms and hand), motor grad 0-5 for each (sum = subtest total 0-50 with 0 being worst score and 50 being full motor function in all muscles); 4. Prehension ability - 3 grasps (cylindrical, lateral key, tip to tip) - each scored 0-4 (sum=subtest score, 0-12 with 0 being worst function and 12 being no dysfunction); 5 Prehension performance - 6 prehension tasks (pour water, open jars, pick up and turn key, transfer 9 pegs from board, pick up four coins and place in slot and screw 4 nuts on bolt - each scored 0-5 (sum=subtest score 0-30 with 0 being worst score to 30 being best possible score.

  6. Neuro Quality of Life - Depression Short Form (NQOL-Dep) [ Time Frame: 48 months ]
    Changes in baseline NQOL-Dep scores at 48 months post-operatively. Scores range from 8-40 with 8 being best outcome and 40 being the worst outcome

  7. Neuro Quality of Life - Upper Extremity Short Form (NQOL-UEF) [ Time Frame: 48 Months ]
    Changes in baseline NQOL-UEF scores at 48 months post-operatively. Scores range from 8-40 with 40 being the best outcome and 8 being the worst possible outcome.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with a traumatic cervical spine injury with little to no use of his/her arms/hands.
Criteria

Inclusion Criteria

  1. Age 18-65, inclusive
  2. At least 3 months of non-operative rehab therapy
  3. Mentally and physically willing and able to comply with evaluations
  4. Less than 36 months post-injury
  5. Stable ASIA scores with no evidence of functional improvement in motor or sensory examination for at least 3 months
  6. ASIA A or B determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
  7. EMG/NCS verifies intact innervation (normal CMAPs) to the paralyzed target muscles below the level of injury
  8. Functional electrical stimulation (FES) will be performed. Subject must have clinically normal MRC grade 5/5 donor (axonal) function
  9. Injury Level C4-C8

Exclusion Criteria

  1. Active infection at the operative site or systemic infection
  2. Any return or ongoing clinical recovery of distal motor function
  3. Mentally or physically compromised that will prevent them from complying with evaluations.
  4. Immunologically suppressed
  5. Currently undergoing long-term steroid therapy
  6. Active malignancy
  7. Pregnant
  8. Significant joint contractures and/or limitations in passive range of motion in the arm or hand, per treating surgeon's discretion
  9. Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits.
  10. Patients who are planning on undergoing a tendon transfer during the study period or who have had a tendon transfer in the past.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023591


Contacts
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Contact: Linda A Koester, BS 314-362-7368 koesterl@wustl.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Anthony Bet, BS    650-683-5823    abet0915@stanford.edu   
Contact: Thomas Wilson, MD       wilsontj@stanford.edu   
Principal Investigator: Thomas J Wilson, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: George Jimsheleishvili, MD    305-243-4781    gxi150@med.miami.edu   
Contact: Patricia Graham, MS    305-243-5119    pgraham1@med.miami.edu   
Principal Investigator: Stephen S Burks, MD         
Sub-Investigator: Allan D. Levi, MD         
United States, Maryland
Johns Hopkins University Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Bronwyn Slobogean    410-502-3293    bslobog1@jhmi.edu   
Principal Investigator: Allan Belzberg, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Karen Sagher    734-975-2589    kfrisch@med.umich.edu   
Contact: Kate Chang    734-975-2589    katewc@med.umich.edu   
Principal Investigator: Yaaman Saadeh, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Linda Koester, BS    314-362-7368    koesterl@wustl.edu   
Sub-Investigator: Neringa Juknis, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Leah Coghlan, BSN    215-615-5436    ncrdneuroicu@uphs.upenn.edu   
Contact: Sydney Churchill    215-595-4584    ncrdneuroicu@uphs.upenn.edu   
Principal Investigator: Eric Zager, MD         
United States, Texas
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Contact: Amber Behne, CCRP    346-238-6424    abehne@houstonmethodist.org   
Contact: Rachel Markley, MPH    713-441-3770    rmarkley@houstonmethodist.org   
Principal Investigator: Amir Faraji, MD         
The University of Texas Houston Health Science Center Terminated
Houston, Texas, United States, 77030
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kirstianna Lombardi, BA/MA    801-585-9821    u6039943@utah.edu   
Contact: Mark Mahan, MD       mark.mahan@hsc.utah.edu   
Principal Investigator: Mark Mahan, MD         
Canada, Alberta
Alberta Health Services - Foothills Medical Center Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Ish Bains    403-944-4334    Ish.Bains@albertahealthservices.ca   
Principal Investigator: Rajiv Midha, MD         
Sponsors and Collaborators
Washington University School of Medicine
Stanford University
University of Pennsylvania
University of Michigan
University of Calgary
University of Utah
United States Department of Defense
The Methodist Hospital Research Institute
University of Miami
Investigators
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Principal Investigator: Wilson Z Ray, MD Washington University School of Medicine
More Information
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Additional Information:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04023591    
Other Study ID Numbers: SC180063
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data. Only aggregate data will be published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Washington University School of Medicine:
tetraplegia
spinal cord injury
quadriplegia
nerve transfer
Additional relevant MeSH terms:
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Spinal Cord Injuries
Quadriplegia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations