Spinal Stimulation and Gait Training to Improve Mobility in TBI

NCT ID: NCT06886152

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-09-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcutaneous Spinal Cord Stimulation

Intervention Type: PROCEDURE

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

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.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: OTHER

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

Interventions

Transcutaneous Spinal Cord Stimulation

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

Intervention Type: PROCEDURE

Sham

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Karen J. Nolan, PhD

Associate Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

Central Contacts

Sharon Franco

Role: CONTACT

sfranco@kesslerfoundation.org

973-324-3521

Kathleen Goworek

Role: CONTACT

kgoworek@kesslerfoundation.org

973-324-3560

Other Identifiers

R-1260-24

Identifier Type: -

Identifier Source: org_study_id