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NCT06541041 · ClinicalTrials.gov registry record
Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury
A clinical trial of Tetraplegia and Cervical Spinal Cord Injury, sponsored by Stanford University.
- Recruiting
- Registry status
- 10
- Enrollment target
- 1
- Study location
NCT06541041 is a study of Tetraplegia and Cervical Spinal Cord Injury that is actively recruiting participants, run by Stanford University. The registered enrollment target is 10 participants, below the 19-participant average among 23 other Tetraplegia trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06541041, a study of Tetraplegia and Cervical Spinal Cord Injury, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- 10 participants
- Enrollment target
- 1
- Study location
Study 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 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 a
Conditions Studied
Interventions
- DEVICE Brief intraoperative electrical stimulation
- DEVICE Temporary Postoperative Peripheral Nerve Stimulation
Study Locations (1)
California
- Stanford University/Stanford Health Care - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-02-10 |
| Est. Completion | 2028-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06541041
The ClinicalTrials.gov registry entry for NCT06541041 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 19-participant average among 23 other Tetraplegia trials with a reported enrollment target (47% lower). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Tetraplegia appearing as the primary indexed condition, and to 2 interventions - of which Brief intraoperative electrical stimulation is the first listed.
NCT06541041 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06541041 about?
NCT06541041 is a clinical study titled "Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury". 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 ...
What is the current status of trial NCT06541041?
This trial is currently recruiting. The enrollment target is 10 participants. The study started on 2025-02-10. Estimated completion is 2028-09.
What conditions does trial NCT06541041 study?
This clinical trial studies the following conditions: Tetraplegia, Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis, Cervical Spinal Cord Paralysis, Tetraplegic Spinal Paralysis.
What interventions are being tested in trial NCT06541041?
The interventions under investigation include: Brief intraoperative electrical stimulation (DEVICE), Temporary Postoperative Peripheral Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT06541041?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06541041 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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