No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Study type
Observational
Participants needed
10 (estimated)
Sponsor
Stanford University · Other
Who this trial is looking for
This trial is looking for adults with cervical spinal cord injury who have no hand function. Participants will undergo nerve transfer surgery along with electrical stimulation to assess improvements in hand movement and pain.
Are You a Good Fit for This Trial?
You may be able to join if
I have a cervical spinal cord injury.
I am between 18 and 65 years old.
I can read and write in English.
I have a stable muscle function for at least 3 months.
I have not had prior surgery for restoring hand function.
I meet specific criteria for nerve transfer surgeries targeting finger movement.
I am mentally and physically able to participate in assessments.
I have no ongoing recovery from my injury.
You may not be able to join if
I have an implanted electronic device like a pacemaker.
I have an active infection at the surgery site.
I am currently pregnant.
I have a joint contracture limiting my range of motion.
I have an active malignancy.
I lack support for follow-up visits.
I have had previous tendon transfer surgery.
I am planning other surgical procedures for hand function.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 electri…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Cervical spinal cord injury, ASIA A or ASIA B
2. International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C7
3. Agreed upon surgical plan includes at least 1 nerve transfer targeting finger flexion with the anterior inte…
Inclusion Criteria:
1. Cervical spinal cord injury, ASIA A or ASIA B
2. International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C7
3. 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
4. Age 18-65 years
5. Mentally and physically able to comply with evaluations and assessments
6. 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
7. Muscle grade at least 4+/5 on the Medical Research Council (MRC) scale in the territory of the donor nerve(s)
8. Stable function for at least 3 months (i.e., no ongoing recovery)
9. Non-operative rehabilitation for at least 3 months
10. Able to read and write in English at a level necessary to complete the questionnaires
Exclusion Criteria:
1. Contraindication to electrical stimulation, including any implanted electronic device such as a pacemaker or intrathecal drug delivery pump
2. Active infection at the operative site or systemic infection
3. Active malignancy
4. Pregnancy
5. Joint contractures or limited passive range of motion that would limit recovery of function
6. Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits
7. Previous tendon transfer or other surgery for restoration of function following cervical spinal cord injury
8. Planned tendon transfer surgery or other surgery for restoration of function following cervical spinal cord injury
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