Status:
RECRUITING
Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury
Lead Sponsor:
Stanford University
Collaborating Sponsors:
United States Department of Defense
Conditions:
Cervical Spinal Cord Injury
Cervical Spinal Cord Paralysis
Eligibility:
All Genders
18-65 years
Brief Summary
The goal of this prospective observational study is to determine whether brief intraoperative electrical stimulation and temporary postoperative electrical stimulation improve motor and/or pain outcom...
Detailed Description
Background: Spinal cord injury (SCI) is a major problem facing the general public, with particular relevance for military personnel, given the high frequency of SCI in combat-related injuries. Nerve ...
Eligibility Criteria
Inclusion
- Cervical spinal cord injury, ASIA A or ASIA B
- International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C7
- Agreed upon surgical plan includes at least 1 nerve transfer targeting finger flexion with the anterior interosseous nerve as the recipient and at least 1 nerve transfer targeting finger extension with the posterior interosseous nerve as the recipient
- Age 18-65 years
- Mentally and physically able to comply with evaluations and assessments
- Upper motor neuron pattern of injury in the recipient nerve with planned surgery 36 months or less from the time of injury OR lower motor neuron pattern of injury in the recipient nerve with planned surgery 9 months or less from the time of injury
- Muscle grade at least 4+/5 on the Medical Research Council (MRC) scale in the territory of the donor nerve(s)
- Stable function for at least 3 months (i.e., no ongoing recovery)
- Non-operative rehabilitation for at least 3 months
- Able to read and write in English at a level necessary to complete the questionnaires
Exclusion
- Contraindication to electrical stimulation, including any implanted electronic device such as a pacemaker or intrathecal drug delivery pump
- Active infection at the operative site or systemic infection
- Active malignancy
- Pregnancy
- Joint contractures or limited passive range of motion that would limit recovery of function
- Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits
- Previous tendon transfer or other surgery for restoration of function following cervical spinal cord injury
- Planned tendon transfer surgery or other surgery for restoration of function following cervical spinal cord injury
Key Trial Info
Start Date :
February 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06541041
Start Date
February 10 2025
End Date
September 1 2028
Last Update
February 19 2025
Active Locations (1)
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1
Stanford University/Stanford Health Care
Palo Alto, California, United States, 94304