Spinal Stimulation and Gait Training to Improve Mobility in TBI (DOD SS)

Transcutaneous Spinal Stimulation and Gait Training to Improve Mobility and Motor Control in Individuals With Traumatic Brain Injury

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Traumatic Brain Injury; Traumatic Brain Injury (TBI); Hemiplegia and Hemiparesis
• Intervention / Treatment: Procedure: Transcutaneous Spinal Cord Stimulation; Other: Sham

Detailed Description

The fundamental hypothesis guiding this proposal is that transcutaneous spinal cord stimulation combined with gait training for individuals with hemiplegic TBI will lead to improved: modulation of corticospinal networks, functional mobility, gait symmetry, standing posture, balance, and motor efficiency compared to gait training with sham stimulation.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharon Franco; Phone Number: 973-324-3521; Email: sfranco@kesslerfoundation.org
• Study Contact Backup: Name: Kathleen Goworek; Phone Number: 973-324-3560; Email: kgoworek@kesslerfoundation.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan Abilitylab
      • Principal Investigator: Arun Jayaraman
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Kessler Foundation
      • Principal Investigator: Karen J Nolan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Transcutaneous Spinal Cord Stimulation; A portable transcutaneous spine stimulator (Digitimer ®, USA) will supply biphasic stimulation superficial to the thoracolumbar spine.
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.	Other: Sham; A portable transcutaneous spine stimulator (Digitimer ®, USA) will be applied superficially with no electrical current.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 20, 2025

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Brain Injuries, Traumatic; Paresis; Hemiplegia; salicylhydroxamic acid
• Other Study ID Numbers: R-1260-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No