An observational study in Cervical Spinal Cord Injury, Cervical Spinal Cord Paralysis and Tetraplegia, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Stanford University · Observational
Among 122 studies in Quadriplegia with a site in United States — 43 open to participants now, 50 under way, 2 of them phase 3. Quadriplegia · United States.
Among the 122 studies in Quadriplegia with a site in United States, this one is the 9th largest by planned enrollment of the 10 observational ones that give a count, is one of 10 that started in 2025, is one of 10 observational ones, reaches primary completion later than 38 of the 49 other live ones, and was the 104th registered.
222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.
Browse Quadriplegia studies →43 of the 122 studies in Quadriplegia with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 18–80
Neuralink Corp · Sites in United States
Ages 18+
Northwell Health · Sites in United States
Ages 21–75
NervGen Pharma · Sites in United States, Canada
Ages 18–75
James J. Peters Veterans Affairs Medical Center · Sites in United States
Ages 22+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 57 Quadriplegia studies recruiting now, 17 (30%) set no upper age limit and 28 (49%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
122 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 14 · Phase 3 7 · Phase 4 4
First in 1989; this study’s year is marked. 10 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10 is below the median of 33 across 22 observational studies indexed under Quadriplegia.
Median enrollment 14 across the 111 interventional studies, 34 across the 10 observational. Of the 61 that completed or were terminated, 29 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 122 have an industry lead sponsor. The 10 most frequent:
Stanford University is the lead sponsor of 2,170 studies on the registry; 433 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Stanford University has 2 studies filed under Quadriplegia — fewer than ten, so there is no comparison to draw.
16 of the studies in Quadriplegia with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07799532Phase 3NervGen PharmaA Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury | 2027-07 |
| NCT07625332Phase 3Northwell HealthPilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI) | 2027-08 |
| NCT05423600Virginia Commonwealth UniversityTransspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia | 2026-11 |
| NCT06295146University of PittsburghVirtual Peer Coaching in Manual Wheelchair Skills | 2026-12-30 |
| NCT05626816MetroHealth Medical CenterAcute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury | 2026-12-31 |
Add all 16 to your calendar (.ics) → With an account.
Among the 122 studies in Quadriplegia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
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 transfer surgery is one option for restoring function in cervical SCI patients that shows great promise. A nerve transfer involves sacrificing a working nerve that arises from a spinal cord segment above the zone of injury and connecting it to a non-working nerve to reinnervate a target muscle. Restoring hand function is consistently rated by SCI patients, including our lived experience consultants, as most important, even more important than walking or bowel/bladder control. Nerve transfer surgery has been shown to be effective in restoring hand function, but additional improvements are needed, especially for restoring grasp. Furthermore, pain is a significant problem in patients with cervical SCI, with an unmet need for options for treating pain in these patients. Peripheral nerve electrical stimulation has been shown to improve axonal regeneration, muscle reinnervation, and motor recovery and has been used to treat neuropathic pain. Thus, the use of peripheral nerve electrical stimulation has the potential to simultaneously improve motor and pain outcomes in cervical SCI patients undergoing nerve transfer surgery but has never been studied.
Objectives/Hypotheses:
The investigators hypothesize that brief intraoperative electrical stimulation of the donor nerves will result in improved motor outcomes compared to standard nerve transfer. We also hypothesize that 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.
Specific Aim:
Compare motor and pain outcomes for nerve transfers in cervical spinal cord injury patients with and without peripheral nerve stimulation.
Study Design:
A single center, unblinded, single arm, non-randomized, observational design will be utilized. A total of 10 patients with cervical spinal cord injury classified as ASIA A or B, with International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C7 will be recruited and will undergo standard end-to-end nerve transfer surgery targeting restoration of finger extension (posterior interosseous nerve recipient) and finger flexion (anterior interosseous nerve recipient) according to standard clinical care. The test intervention will consist of intraoperative brief electrical stimulation of the donor nerves and postoperative electrical stimulation via a temporary, implantable peripheral nerve stimulator. Intraoperative brief electrical stimulation (BES) will be performed using a handheld nerve stimulator to stimulate the donor nerves at 2 mA with a 200 µs pulse duration for 10 minutes. The implantable peripheral nerve stimulator will be programmed to optimize postoperative pain control on an individualized basis. The peripheral nerve stimulator will be explanted after 60 days, as is intended for this device. The primary outcomes will be manual motor testing graded on the Medical Research Council (MRC) scale (0-5) for the extensor digitorum communis (EDC) and flexor pollicis longus (FPL) and the Numeric Rating Scale (NRS) for pain in the treated extremity (0-10). Patients will have a baseline preoperative electrodiagnostic study and functional electrical stimulation performed, with the decision for surgery occurring as part of standard clinical care. Assessments will occur preoperatively and postoperatively at 3, 6, 12, 24, and 36 months. The researchers will compare these data to a retrospective group of patients who underwent similar nerve transfer surgery without intraoperative or postoperative electrical stimulation.
Cervical spinal cord injury patients aged 18-65 years with neurological level of injury C6 or C7 and limited or no hand function
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a retrospective group that has already undergone standard nerve transfer surgery targeting hand function without intraoperative or postoperative electrical stimulation. No additional patients will be enrolled in this group.
This is a prospectively enrolled group that will undergo standard nerve transfer surgery targeting hand function plus brief intraoperative electrical stimulation of the donor nerves and placement of a temporary peripheral nerve stimulator to allow postoperative electrical stimulation of the donor nerves for up to 60 days. All care provided, including the surgery, intraoperative electrical stimulation, postoperative electrical stimulation, and postoperative hand therapy, will be provided according to standard of care and is not considered experimental.
Device: Brief intraoperative electrical stimulation · Device: Temporary Postoperative Peripheral Nerve Stimulation
Intraoperative brief electrical stimulation (BES) will be performed using a handheld nerve stimulator (Checkpoint Guardian) to stimulate the donor nerves at 2 mA with a 200 µs pulse duration for 10 minutes per nerve.
Also known as: Checkpoint Guardian Nerve Stimulator
An implantable temporary peripheral nerve stimulator (SPRINT PNS System) will be placed during the surgery with one lead for each donor nerve. The implantable peripheral nerve stimulator will be programmed to optimize postoperative pain control on an individualized basis. The peripheral nerve stimulator will be explanted after 60 days, as is intended for this device.
Also known as: SPRINT PNS System
Composite Motor Score
A composite sum of the manual motor testing of the extensor digitorum communis and flexor pollicis longus muscles on the MRC scale (0-5 for each muscle, 0-10 composite score) will be calculated (composite motor score).
Time frame: 36 Months Postoperative
Percentage of Baseline Pain
The percentage of baseline pain in the operated limb will be calculated by dividing the postoperative NRS score by the baseline NRS score and multiplying by 100.
Time frame: 6 Months Postoperative
Manual Motor Testing
A composite sum of the manual motor testing of the extensor digitorum communis and flexor pollicis longus muscles on the MRC scale (0-5 for each muscle, 0-10 composite score) will be calculated (composite motor score).
Time frame: 6, 12, and 24 Months Postoperative
Percentage of Baseline Pain
The percentage of baseline pain in the operated limb will be calculated by dividing the postoperative NRS score by the baseline NRS score and multiplying by 100.
Time frame: 3 Weeks, 12, 24, and 36 Months Postoperative
DASH Score
Patients will complete the Disabilities of the Arm, Shoulder, and Hand Questionnaire. The DASH score ranges from 0-100, with 0 representing normal function of the upper extremities and 100 representing maximal functional impairment.
Time frame: 6, 12, 24, and 36 Months Postoperative
MHQ Score
Patients will complete the Michigan Hand Questionnaire. The MHQ has a score range of 0-100, with 0 representing the worst hand function and 100 representing ideal hand function.
Time frame: 6, 12, 24, and 36 Months Postoperative
SCIM III Score
Patients will complete the Spinal Cord Independence Measure III Questionnaire. The SCIM III score ranges from 0-60, with 0 representing complete dependence and 60 representing complete independence.
Time frame: 6, 12, 24, and 36 Months Postoperative
Zung SDS
Patients will complete the Zung Self-rated Depression Scale Questionnaire. Zung SDS score ranges from 20-80, with normal (\<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (\>70).
Time frame: 6, 12, 24, and 36 Months Postoperative
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Sep 2028, 43 months after the start.
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