Spinal Stimulation and Gait Training to Improve Mobility in TBI

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Kessler Foundation
Study ID
NCT06886152
Status
Not Yet Recruiting

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Conditions

  • Hemiplegia and Hemiparesis
  • Traumatic Brain Injury
  • Traumatic Brain Injury (TBI)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous Spinal Cord Stimulation — PROCEDURE
    A portable transcutaneous spine stimulator (Digitimer ®, USA) will supply biphasic stimulation superficial to the thoracolumbar spine.
  • Sham — OTHER
    A portable transcutaneous spine stimulator (Digitimer ®, USA) will be applied superficially with no electrical current.

Study Details

The purpose of this research study is to assess the effects of receiving transcutaneous spinal stimulation while performing walking exercises compared to completing walking exercises without spinal stimulation for individuals with hemiplegic TBI.

Key Dates

Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

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

Arms

  • Experimental: TBI with Stim
    Participants with TBI will be asked to come in 3 days a week for 6 weeks for walking training provided by a trained, licensed physical therapist. Electrodes will be placed on the surface of the skin along the spinal cord to provide stimulation during walking.
  • Sham Comparator: TBI with Sham
    Participants with TBI will be asked to come in 3 days a week for 6 weeks for walking training provided by a trained, licensed physical therapist. Electrodes will be placed on the surface of the skin along the spinal cord but will not provide stimulation during walking.

Primary Outcome Measure

10MWT (Aim 1) [ Time Frame: Change from Baseline 10MWT at 6 weeks and 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611
Arun Jayaraman (PRINCIPAL_INVESTIGATOR)
Kessler FoundationWest OrangeNew Jersey07052
Karen J Nolan (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Shirley Ryan AbilityLab· Chicago, ILKessler Foundation· West Orange, NJ

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