NCT06541041View on ClinicalTrials.gov

Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury

RecruitingOBSERVATIONAL
Enrollment

10

Participants

Timeline

Start Date

February 10, 2025

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
Cervical Spinal Cord InjuryCervical Spinal Cord ParalysisTetraplegiaTetraplegia/TetraparesisTetraplegic Spinal Paralysis
Interventions
DEVICE

Brief intraoperative electrical 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.

DEVICE

Temporary Postoperative Peripheral Nerve Stimulation

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.

Trial Locations (1)

94304

RECRUITING

Stanford University/Stanford Health Care, Palo Alto

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Stanford University

OTHER