Spinal zaps plus treadmill training may help TBI survivors walk again
NCT ID NCT06886152
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study will test whether a mild electrical stimulation applied to the lower back, combined with walking exercises, can improve mobility and balance in people with traumatic brain injury (TBI) who have weakness on one side. Thirty adults with a non-penetrating TBI at least two years ago will be randomly assigned to receive either real stimulation or a sham (no current) during gait training. The goal is to see if this approach can boost walking speed, endurance, and overall quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous spinal cord stimulation
- What this could lead to
- If it works, this could point toward a non-invasive way to improve walking and balance after traumatic brain injury.
- What could go wrong
- This is a small, early-stage study with only 30 people. The sham group may show similar improvements, and results may not apply to all TBI patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Kessler Foundation
West Orange, New Jersey, 07052, United States
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Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
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Other studies related to the condition(s) this trial covers.
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- Bedside ultrasound could flag hidden brain injury decline
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- Machine learning may forecast brain decline after head injury
- MRI tracer could expose hidden brain energy crisis after head injury