Actively Recruiting
Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury
Led by Stanford University · Updated on 2025-02-19
10
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 outcomes for patients with cervical spinal cord injury undergoing standard of care nerve transfer surgery to improve hand function. The main hypotheses include: Hypothesis #1: Brief intraoperative electrical stimulation of the donor nerves will result in improved motor outcomes (hand function) compared to standard nerve transfer surgery in patients with cervical spinal cord injuries. Hypothesis #2: Placement of a temporary peripheral nerve stimulator for 60 days of postoperative electrical stimulation will result in improved pain outcomes compared to standard nerve transfer surgery in patients with cervical spinal cord injuries. Researchers will prospectively enroll patients with cervical spinal cord injury and no hand function who will undergo standard of care nerve transfer surgery combined with standard of care brief intraoperative electrical stimulation and temporary postoperative electrical stimulation. Motor and pain outcomes will be compared to a retrospective group of patients who underwent nerve transfer surgery without intraoperative or postoperative electrical stimulation. Participants will receive standard medical care (nothing experimental) as part of this study. Participants will: * Have a preoperative assessment including physical examination, electrodiagnostic studies, functional electrical stimulation, and will complete questionnaires assessing function and quality of life * Agree upon a surgical plan, including the specific nerve transfers to be performed and whether to include brief intraoperative electrical stimulation and/or temporary postoperative electrical stimulation before being considered for enrollment in the study * Will undergo standard of care nerve transfer surgery, with at least one nerve transfer targeting improvement in hand function and will receive brief intraoperative electrical stimulation of the donor nerves and placement of a temporary peripheral nerve stimulator * Will follow-up with the surgeon 3, 6, 12, 24, and 36 months after the surgery * Will have a physical examination and will complete questionnaires at the postoperative visits * Will participate in hand therapy following the operation * Will be eligible for placement of a permanent peripheral nerve stimulator, depending on response to the temporary peripheral nerve stimulator.
CONDITIONS
Official Title
Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have cervical spinal cord injury classified as ASIA A or ASIA B
- Have neurological injury level at C6 or C7 according to International Standards for Neurological Classification of Spinal Cord Injury
- Surgical plan includes at least one nerve transfer targeting finger flexion with the anterior interosseous nerve and one targeting finger extension with the posterior interosseous nerve
- Aged between 18 and 65 years
- Mentally and physically able to comply with study evaluations and assessments
- Surgery planned within 36 months of injury for upper motor neuron pattern or within 9 months for lower motor neuron pattern in recipient nerve
- Muscle grade of at least 4+/5 on the Medical Research Council scale in donor nerve area
- Stable function for at least 3 months with no ongoing recovery
- Underwent non-operative rehabilitation for at least 3 months
- Able to read and write English to complete questionnaires
You will not qualify if you...
- Contraindications to electrical stimulation, including implanted electronic devices such as pacemakers or intrathecal drug pumps
- Active infection at surgery site or systemic infection
- Active cancer
- Pregnancy
- Joint contractures or limited passive range of motion that would limit recovery
- Lack of social support or infrastructure to attend follow-up visits
- Previous tendon transfer or surgery for function restoration after cervical spinal cord injury
- Planned tendon transfer or other surgery for function restoration after cervical spinal cord injury
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Trial Site Locations
Total: 1 location
1
Stanford University/Stanford Health Care
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
T
Thomas J Wilson, MD, MPH
CONTACT
A
Adrian Valladarez
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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