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RECRUITING
NCT06225245
NA

Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

Summary

This study will test whether spinal stimulation combined with rehabilitation can improve arm and hand function in people with tetraplegia after spinal cord injury. Tetraplegia causes weakness or paralysis in the arms and legs. The stimulation sends electrical pulses through a paddle placed near the spinal cord in the neck. Researchers will study changes in arm and hand function and how the brain and spinal cord respond. The study has two phases. \*\*Phase 1: Initial testing\*\* Participants will: * Complete screening to see whether they qualify. * Have surgery to place a stimulation paddle in the neck, with wires extending outside the body. * Take part in arm and hand exercises with spinal stimulation. * Complete tests to measure their response. The study team will check whether each participant meets the criteria to continue. Those who qualify may choose to enter Phase 2. Those who do not qualify will have the paddle and external wires removed and will not enter Phase 2. \*\*Phase 2: Permanent implant\*\* Participants will have surgery to implant a battery that powers the stimulation system. They will continue arm and hand exercises with stimulation. The study team will adjust the settings to support each participant's movement goals.

Key Details

Gender

All

Age Range

22 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-08-06

Completion Date

2030-01-01

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DEVICE

Epidural Spinal Stimulation (ESS)

An implanted paddle array delivers electrical stimulation near the spinal cord in the neck. Settings are adjusted to each participant's tolerance and arm and hand movement goals. Only trained study staff operate the stimulation controller. For participants receiving a permanent implant, home stimulation programs are established and refined before study completion.

BEHAVIORAL

Upper extremity rehabilitation

Participants complete arm and hand rehabilitation paired with cervical epidural spinal stimulation to work toward their movement goals.

Locations (1)

The Methodist Hospital Research Institute

Houston, Texas, United States