Department of Defense Nerve Transfer Trial

In 2012, the Department of Defense (DoD) awarded Washington University and Dr. Ray a multi-million dollar grant to study 20 patients at Washington University who underwent a nerve transfer procedure.  This clinical trial completed enrollment, and all patients are being followed post-operatively. 

 Information is available about Dr. Ray’s contributions and about this trial on the DoD website.

In 2019, The DoD has awarded Washington University and Dr. Ray another multi-million dollar grant to run a similar clinical trial.  This study will be a multi-site study and will enroll 70 patients across the US and Canada.  

Enrollment has begun for this study.  If you would like to get more information or submit your information to see if you may qualify, please  complete our intake questionnaire.  There is no obligation to participate in the study by completing this short questionnaire.  

The DoD grant does not pay for standard of care tests nor surgery.  A portion of the patient’s outpatient therapy will be paid for by the grant.

Study Design

  • A prospective, multi-institutional, non-randomized, single arm design will be utilized.
  • 70 subjects will be enrolled at up to 7 sites across the US and Canada.
  • Recruitment will last approximately 12 months.
  • Participant follow-up will be for 48 months post-surgery.

Hypothesis and Purpose

Peripheral nerve transfers in patients with a traumatic cervical spinal cord injury (SCI) will improve motor function, functional independence and patient quality of life.

The long-term objective of this clinical trial is to establish and validate clinical guidelines on the use of nerve transfers to restore lower (distal) motor function following a cervical SCI.

General Inclusion and Exclusion Criteria

  • 18-65 years of age
  • Must have received at least 3 months of rehab therapy
  • American Spinal Injury Association (ASIA) A or B at time of injury
  • SCI Level C4-C8
  • No current infections
  • No current malignancy
  • No previous tendon transfers
  • No planned tendon transfers during study period
  • Social support available to commit to visits/therapy sessions
  • No significant joint contractures 

Study Activities

Study participants are expected to attend all follow-up study visits and complete all exams/questionnaires.

Throughout the clinical trial, the participants will receive weekly hand therapy.  A portion of this will be covered by the DoD grant.  The participant is expected to do the recommended hand therapy exercises at home in order to obtain the greatest motor function recovery possible.

Hand therapy plays an important role in addressing motor re-education, regaining functional strength and maintaining proper muscle length following the nerve transfer surgery.  

Listed below are the study visits and associated procedures/exams.

Your participation in the study will last approximately 48 months after your surgery.

VISIT 1 – SCREENING/BASELINE VISIT

This visit will occur over several days:

  • Visit with Dr. Ray:
    • Prior to appointment, the patient will send in a recent electromyography/nerve conduction test (EMG/NCT), and a recent upper extremity motor exam for review.  An appointment will be made if the tests indicate the patient may be a potential candidate for a nerve transfer surgery.
    • A physical exam will be performed.
    • If indicated, Dr. Ray will offer a nerve transfer procedure.  He will educate the patient on the procedure.  The patient will be offered the opportunity to participate in the research study.  
    • Participation in the clinical trial is voluntary. Patients may have surgery without participating in the study.
    • Patients will complete questionnaires.
    • Pictures/videos of patient’s arm/hand movement will be recorded.
  • Neurologist Visit:
    • A neurologist will perform an ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injuries) exam – a thorough neurological exam comparing sensation from a spot above the SCI (cheek) to several spots below the SCI.  There is also a motor exam to test upper and lower extremity strength.
  • Hand Surgeon:
    • The hand surgeon examines the patient and verifies the diagnosis and gives a second opinion on the treatment being offered.
  • Hand Therapist:
    • The therapist will examine the patient and educate him/her on the recovery/therapy program.
    • The therapist will perform tests to examine range of motion/sensation/motor function and ability to perform everyday tasks.

VISIT 2 – SURGERY

Participant will undergo the standard of care surgery that is recommended by Dr. Ray.

The study does not determine or change the medical treatment the patient will receive.

 

VISITS 3-8 (6/12/18/24/36/48 MONTHS POSTOP)

At each post-op follow-up visit, the following will occur:

  • Exam by neurosurgeon
  • Motor exam on upper extremities
  • Patient will complete questionnaires
  • Range of Motion pictures/videos
  • Visit to the hand therapist for treatment and exams

Post-op Therapy

Post-op therapy is an important part of the patient’s recovery and return to function.  Weekly post-op therapy may begin at approximately 2 weeks after surgery.

The amount and type of therapy will be determined by Dr. Ray and the therapist.  

Study participants may use the therapists at Washington University or a therapist closer to their home for their weekly therapy.

A portion of the weekly therapy will be paid for by the Department of Defense grant.  

If you or a loved one is interested in learning more about participating in this clinical trial, please complete our intake form.  A coordinator will contact you within a few days.

OR

You can directly contact Dr. Ray’s research coordinator:

Linda Koester

Phone: 314-362-7368

Email: koesterl@wustl.edu