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Arm B: Standard nerve transfer surgery plus intraoperative and postoperative electrical stimulation for Quadriplegia

N/A
Waitlist Available
Led By Thomas J Wilson, MD, MPH
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12, 24, and 36 months postoperative
Awards & highlights

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 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.

Eligible Conditions
  • Quadriplegia
  • Spinal Cord Injury
  • Quadriplegia/Quadriparesis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12, 24, and 36 months postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12, 24, and 36 months postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite Motor Score
Secondary study objectives
DASH Score
MHQ Score
Manual Motor Testing
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: Standard nerve transfer surgery plus intraoperative and postoperative electrical stimulationExperimental Treatment2 Interventions
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.
Group II: Arm A: Standard nerve transfer surgery without electrical stimulationExperimental Treatment0 Interventions
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.

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Who is running the clinical trial?

United States Department of DefenseFED
891 Previous Clinical Trials
332,468 Total Patients Enrolled
4 Trials studying Quadriplegia
202 Patients Enrolled for Quadriplegia
Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,433 Total Patients Enrolled
4 Trials studying Quadriplegia
114 Patients Enrolled for Quadriplegia
Thomas J Wilson, MD, MPHPrincipal InvestigatorStanford University
~7 spots leftby Sep 2028