Clinical trial NCT06886152: Spinal Stimulation and Gait Training to Improve Mobility in TBI
Official title: Transcutaneous Spinal Stimulation and Gait Training to Improve Mobility and Motor Control in Individuals With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Traumatic Brain Injury (TBI)
Hemiplegia and Hemiparesis
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Shirley Ryan AbilityLab
First posted: 2025-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 10MWT (Aim 1)
timeFrame: Change from Baseline 10MWT at 6 weeks and 3 months
measure: 6MWT (Aim 1)
timeFrame: Change from Baseline 6MWT at 6 weeks and 3 months
measure: TUG (Aim 1)
timeFrame: Change from Baseline 6MWT at 6 weeks and 3 months
measure: DGI (Aim 1)
timeFrame: Change from Baseline DGI at 6 weeks and 3 months
measure: Berg Balance Scale (Aim 1)
timeFrame: Change from Baseline Berg at 6 weeks and 3 months
measure: Temporospatial Loading (Aim 1)
timeFrame: Change from Baseline at 6 weeks and 3 months
measure: Joint Range of Motion (kinematics) (Aim 2)
timeFrame: Change from Baseline at 6 weeks and 3 months
measure: Transcranial magnetic stimulation (TMS) (Aim 2)
timeFrame: Change from Baseline at 6 weeks and 3 months
measure: Participation Objective Participation Subjective (Aim 3)
timeFrame: Change from Baseline at 6 weeks and 3 months
measure: Community Integration Questionnaire (Aim 3)
timeFrame: Change from Baseline at 6 weeks and 3 months
measure: Patient Competency Rating Scale (Aim 3)
timeFrame: Change from Baseline at 6 weeks and 3 months
measure: Perceived Control Scale for Brain Injury (Aim 3)
timeFrame: Change from Baseline at 6 weeks and 3 months
measure: SF-36 (Aim 3)
timeFrame: Change from Baseline at 6 weeks and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: