Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05267951
Status
Recruiting
Apply to this trial

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Open-loop Stimulation — DEVICE
    Spinal cord stimulation will be applied continuously over the skin throughout the intervention session.
  • Close-loop Stimulation — DEVICE
    Spinal cord stimulation will start and stop based on the signals that come from the sensors placed on upper limb muscle surfaces.
  • Functional Task Practice — OTHER
    Exercise therapy consists of repeated functional hand and arm movements

Study Details

The purpose of this study is to assess the efficacy of non-invasive (transcutaneous) closed-loop electrical spinal cord stimulation for recovery of upper limb function (Aim 1) and spasticity (Aim 2) following spinal cord injury.

Key Dates

Start date
Oct 12, 2022
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
9 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Open-loop Stimulation
    Continuous stimulation
  • Experimental: Close-loop Stimulation
    Intended movement-based stimulation.

Primary Outcome Measure

Change from baseline- Graded Redefined Assessment of Strength, Sensation, and Prehension version 2 [ Time Frame: "Repeated measurements once every two weeks throughout the study, an average of 10 months". ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195
Fatma Inanici, MD, Ph.D.
[email protected]
2067872692
Chet T. Moritz, PhD (PRINCIPAL_INVESTIGATOR)
Fatma Inanici, MD, PhD (SUB_INVESTIGATOR)

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By research site
University of Washington· Seattle, WA

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