Paired Spinal Cord and Peripheral Nerve Stimulation to Recover Hand Function in SCI

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT06698224
Status
Not Yet Recruiting

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Conditions

  • Spinal Cord Disease
  • Spinal Cord Injuries (SCI)
  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Spinal cord transcutaneous stimulation — DEVICE
    Physical therapy combined with spinal cord transcutaneous stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord stimulation is a non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.
  • Paired spinal cord and peripheral nerve stimulation — DEVICE
    Physical therapy combined with paired spinal cord-peripheral nerve stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord and peripheral nerve stimulation are both non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.

Study Details

Individuals who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. This project aims to test the effects of pairing spinal cord and nerve stimulation combined with physical therapy training in recovering arms and hand function. The long-term goal is to provide better therapies that will improve the ability of individuals with spinal cord injuries to use their arms and hands to perform everyday tasks, similar to injury before.

Key Dates

Start date
Jan 2, 2025
Status verified
Nov 2024
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
14 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: scTS
    This arm will receive 20 sessions of spinal cord transcutaneous stimulation (scTS) combined with physical therapy.
  • Experimental: scTS+PNS
    This arm will receive 20 sessions of paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS) followed by scTS combined with physical therapy.

Primary Outcome Measure

GRASSP [ Time Frame: From enrollment to the end of treatment at 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
Gail Forrest, Ph.D.
Susan Harkema, Ph.D.
Pawan Sharma, PT. Ph.D.

Find similar trials in West Orange, NJ

By research site
Kessler Foundation· West Orange, NJ

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