Spinal Stimulation and Gait Training to Improve Mobility in TBI

NCT06886152 | Not Yet Recruiting DMC

• 1 other identifier: R-1260-24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (13)

• 10MWT (Aim 1)

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

  Change from Baseline 10MWT at 6 weeks and 3 months

• 6MWT (Aim 1)

  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.

  Change from Baseline 6MWT at 6 weeks and 3 months

• TUG (Aim 1)

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

  Change from Baseline 6MWT at 6 weeks and 3 months

• DGI (Aim 1)

  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.

  Change from Baseline DGI at 6 weeks and 3 months

• Berg Balance Scale (Aim 1)

  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.

  Change from Baseline Berg at 6 weeks and 3 months

• Temporospatial Loading (Aim 1)

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

  Change from Baseline at 6 weeks and 3 months

• Joint Range of Motion (kinematics) (Aim 2)

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

  Change from Baseline at 6 weeks and 3 months

• Transcranial magnetic stimulation (TMS) (Aim 2)

  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).

  Change from Baseline at 6 weeks and 3 months

• Participation Objective Participation Subjective (Aim 3)

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

  Change from Baseline at 6 weeks and 3 months

• Community Integration Questionnaire (Aim 3)

  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.

  Change from Baseline at 6 weeks and 3 months

• Patient Competency Rating Scale (Aim 3)

  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.

  Change from Baseline at 6 weeks and 3 months

• Perceived Control Scale for Brain Injury (Aim 3)

  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.

  Change from Baseline at 6 weeks and 3 months

• SF-36 (Aim 3)

  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.

  Change from Baseline at 6 weeks and 3 months

Study Arms (2)

TBI with Stim

EXPERIMENTAL

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.

Procedure: Transcutaneous Spinal Cord Stimulation

TBI with Sham

SHAM COMPARATOR

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.

Other: Sham

Interventions

Transcutaneous Spinal Cord Stimulation PROCEDURE

A portable transcutaneous spine stimulator (Digitimer ®, USA) will supply biphasic stimulation superficial to the thoracolumbar spine.

TBI with Stim

Sham OTHER

A portable transcutaneous spine stimulator (Digitimer ®, USA) will be applied superficially with no electrical current.

TBI with Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• I have a history of seizure disorder or have a close family member (parent, brother, sister, or child) who has a seizure disorder.

Sponsors & Collaborators

• Kessler Foundation: lead
• Shirley Ryan AbilityLab: collaborator

Study Sites (2)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Hemiplegia; Paresis

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sharon Franco

CONTACT

973-324-3521; sfranco@kesslerfoundation.org

Kathleen Goworek

CONTACT

973-324-3560; kgoworek@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)