Traumatic Brain InjuryDOD SSNCT06886152
Spinal Stimulation and Gait Training to Improve Mobility in TBI
A study testing Transcutaneous Spinal Cord Stimulation in people with Traumatic Brain Injury and Traumatic Brain Injury (TBI), run by Kessler Foundation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury, Traumatic Brain Injury (TBI), Hemiplegia and Hemiparesis
- What is being tested?
- Transcutaneous Spinal Cord Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Arun Jayaraman
Kessler Foundation
West Orange, New Jersey, 07052
Karen J Nolan
About this study
Official title: 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.
Read the 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.
- Being tested
- Transcutaneous Spinal Cord Stimulation, Sham
- Medical subject headings
- Brain Injuries, Traumatic, Hemiplegia, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Spinal Cord StimulationProcedure or surgery
A portable transcutaneous spine stimulator (Digitimer ®, USA) will supply biphasic stimulation superficial to the thoracolumbar spine.
ShamOther
A portable transcutaneous spine stimulator (Digitimer ®, USA) will be applied superficially with no electrical current.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
10MWT (Aim 1)
10 meter walk test is a timed test to evaluate walking speed after TBI and in response to the intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline at 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Responsible party
- Principal investigator, Karen J. Nolan, PhD, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886152
- Sponsor's protocol ID
- R-1260-24
- Acronym
- DOD SS
- Status last verified
- Aug 2025
- First submitted
- 11 Mar 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Stimulation and Gait Training to Improve Mobility and Motor Control in Individuals With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT06886152
- Acronym / sponsor ID
- DOD SS / R-1260-24
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI with Stim | Experimental | Procedure: Transcutaneous Spinal Cord StimulationParticipants 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. |
| TBI with Sham | Sham comparator | Other: ShamParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Spinal Cord StimulationA portable transcutaneous spine stimulator (Digitimer ®, USA) will supply biphasic stimulation superficial to the thoracolumbar spine. | Procedure or surgery | TBI with Stim |
| ShamA portable transcutaneous spine stimulator (Digitimer ®, USA) will be applied superficially with no electrical current. | Other | TBI with Sham |
Primary outcome
10MWT (Aim 1)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Spinal Cord Stimulation in people with Traumatic Brain Injury and Traumatic Brain Injury (TBI), run by Kessler Foundation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Franco (973-324-3521, sfranco@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10MWT (Aim 1) (time frame: Change from Baseline 10MWT at 6 weeks and 3 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.