Back to search results

Spinal Stimulation and Gait Training for Mobility After TBI

This study is testing if combining a procedure called Transcutaneous Spinal Cord Stimulation (a portable device that delivers electrical pulses to your spine) with walking exercises can improve mobility for people who have had a traumatic brain injury (TBI) and experience weakness on one side of their body (hemiplegia or hemiparesis). You might be able to join if you are between 18 and 65 years old, have weakness on one side of your body due to a non-penetrating TBI that happened at least two years ago, and can use a walker or hemiwalker. The researchers want to see if this combination helps improve how far and fast you can walk, and how easily you can move around. The study is currently recruiting 30 participants, but its overall status is unclear.

Study design
This interventional study plans to enroll 30 participants. It compares receiving Transcutaneous Spinal Cord Stimulation with walking exercises to receiving a sham (inactive) stimulation with walking exercises.
What's involved
Participants will undergo walking exercises with either active or sham spinal stimulation. Mobility will be measured at 6 weeks and 3 months.
Compensation
Not stated in the trial record.
Follow-up
Your mobility will be assessed at 6 weeks and 3 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06886152

Spinal Stimulation and Gait Training to Improve Mobility in TBI

Not Yet Recruiting
NAAges 18–65InterventionalTreatment
Kessler Foundation
~30 participants
Updated 2025-09-02 on ClinicalTrials.gov
What's tested:Transcutaneous Spinal Cord StimulationSham

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
10MWT (Aim 1)
Measured over Change from Baseline 10MWT at 6 weeks and 3 months
+12 more outcomes measured

Conditions

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

Explore related trials

HemiplegiaTraumatic Encephalopathy

Where it's being run

2 sites across 2 states
Illinois1
New Jersey1

Who to contact

Sharon Franco
[email protected]
973-324-3521
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Have weakness on at least one side of my body.
No injury to my unaffected side in 6 months.
Be cleared by a physician to participate in this study.
Have had a non-penetrating TBI at least 2 years ago. A non-penetrating injury is an injury where my skull remained closed and no object entered it.
Have enough strength to use a hemiwalker or walker.
Be between 18-65 years of age.
Be medically stable for at least 6 months before enrolling. This means that I have not had an emergency room visit, hospitalization, or medical procedure (such as a surgery) during this period of time.
Able to walk 10 yards with minimal assistance without an ankle-foot orthosis (brace)
Able to respond to and tolerate surface stimulation, as determined by study staff
Have the ability to communicate in English.
Have stable blood pressure.
Be willing and able to give informed consent.
Be able and willing to comply with study procedures, verbal instructions, and follow-up requirements.

Exclusion

Have must have not had physical or occupational therapy or treatment for a balance disorder within 30 days prior to study enrollment. I must not participate in physical or occupation therapy throughout the duration of the study to avoid affecting the study results.
Have any medical issues that affect my unaffected side (such arthritis, fracture, etc.).
Have skin issues that would prevent me from being able to use the surface stimulation (such as a open wound or rash).
Have a pre-existing condition that may make it difficult for me to participate in exercise. (uncontrolled hypertension as described by a physician, heart disease, abnormal heart rate or rhythm, or congestive heart failure).
Have been hospitalized for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
Have an implanted medical or metallic device.
Reduced sensation in my lower limbs and stimulation locations.
Have Botox injections in my legs up to 3 months prior to enrolling.
Have physical therapy for walking.
Have uncontrolled seizure disorder (such as epilepsy)
Have nervous system-related issues (for example Parkinson's disease, multiple sclerosis).
Major changes to my medications throughout the study
Have bone or muscle issues unrelated to traumatic brain injury that interfere with my walking or limit my range of motion in my legs.
Be currently pregnant. Because of potential risk to the fetus, women of child bearing potential will be required to have a pregnancy test before they can enroll in this study. If I am female, and have a positive pregnancy test, I will not be enrolled.
Have any other medical conditions that my doctor or physical therapist feels would affect my ability to use the stimulation or participate in walking training TMS Specific - Exclusion (those with these exclusions can still participate in other parts of the study)
I have a history of seizure disorder or have a close family member (parent, brother, sister, or child) who has a seizure disorder.
I have had unexplained fainting spells.
I have had an active migraine headaches.
I have a past or current history of ringing in the ears (tinnitus) or severe hearing problems.
I am currently taking or withdrawing from any medication that would increase my risk of seizure (determination made in consultation with study physician).
I have a history of alcohol or drug abuse in the prior 3 years.
I have nerve damage outside of my brain or spinal cord (such as in an arm or leg).
I am unwilling to participate in TMS.

What this trial measures

  • 10MWT (Aim 1)Change from Baseline 10MWT at 6 weeks and 3 months

    10 meter walk test is a timed test to evaluate walking speed after TBI and in response to the intervention.

  • 6MWT (Aim 1)Change from Baseline 6MWT at 6 weeks and 3 months

    6 minute walking test to evaluate endurance after TBI and in response to the intervention. Distance is measured for 6 minutes with a greater distance indicating a better outcome.

  • TUG (Aim 1)Change from Baseline 6MWT at 6 weeks and 3 months

    Timed up and go (TUG) is a timed test to measure functional balance and walking ability after TBI and in response to the intervention.

  • DGI (Aim 1)Change from Baseline DGI at 6 weeks and 3 months

    Dynamic Gait Index (DGI) evaluates the ability to modify balance while walking in the presence of external demands after TBI and in response to the intervention. The measure is scored out of 24 with a higher score indicating a better outcome.

  • Berg Balance Scale (Aim 1)Change from Baseline Berg at 6 weeks and 3 months

    Measure to assess static and dynamic balance and fall risk after TBI and in response to the intervention. The scale is scored out of 56 with a high score indicating a better outcome.

  • Temporospatial Loading (Aim 1)Change from Baseline at 6 weeks and 3 months

    Step length, timing during gait cycle, limb symmetry will be collected using instrumented gait walkway and are combined to evaluate gait symmetry.

  • Joint Range of Motion (kinematics) (Aim 2)Change from Baseline at 6 weeks and 3 months

    Kinematics gait data will be collected using a motion capture camera system to provide biomechanical outcomes.

  • Transcranial magnetic stimulation (TMS) (Aim 2)Change from Baseline at 6 weeks and 3 months

    Transcranial magnetic stimulation (TMS) will be used to assay changes in cortical neurophysiology for all subjects using Magstim Rapid2TM 70 mm double coil (or similar device).

  • Participation Objective Participation Subjective (Aim 3)Change from Baseline at 6 weeks and 3 months

    The POPS consists of 26 elements of participation representing 5 categories. For each item the participant rates each element objectively and subjectively.

  • Community Integration Questionnaire (Aim 3)Change from Baseline at 6 weeks and 3 months

    The CIQ is a 15-item instrument used to assess the social role limitations and community interaction of people with brain injury with higher scores indicating greater independence and community integration.

  • Patient Competency Rating Scale (Aim 3)Change from Baseline at 6 weeks and 3 months

    The PCRS is a 30 item self report scale using a 5 point Likert to rate the degree of difficulty in a variety of tasks and functions including measure of awareness of deficits following TBI in daily living, behavioral and emotional function, cognitive abilities, and physical function. Higher score indicates greater competency.

  • Perceived Control Scale for Brain Injury (Aim 3)Change from Baseline at 6 weeks and 3 months

    This scale is 9 items scored on a 4 point Likert. It measures perceived control developed for individuals with acquired brain injury with a higher score indicating higher perceived control.

  • SF-36 (Aim 3)Change from Baseline at 6 weeks and 3 months

    The Short Form (SF) Survey is the most widely used and studied measure of health-related quality of life consisting of 36 items, completed by the participant. Higher average scores indicate a more favorable state of health.