Walking + tSCS for Stroke Survivors

Overseen By Mustapha Mangdow, PT. MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Cardiac disease, Pulmonary disease, Musculoskeletal disorders, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to help stroke survivors improve mobility by combining robot-assisted gait training with transcutaneous spinal cord stimulation (tSCS), a technique using electrical currents to potentially enhance nerve function. The trial compares the effects of this combined treatment with gait training alone. It seeks participants who had a stroke at least six months ago and struggle to walk independently in their community. Participants should not currently engage in treadmill or weight-bearing exercises. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new rehabilitation methods for stroke survivors.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that transcutaneous spinal cord stimulation (tSCS) is generally safe. Studies indicate that individuals using tSCS with rehabilitation experienced no significant changes in blood pressure or heart rate compared to those undergoing rehabilitation alone, suggesting tSCS did not cause major heart-related side effects.

Additionally, tSCS has proven safe for use outside of a hospital setting and has improved strength and movement in individuals with spinal cord injuries. These findings suggest that tSCS is well-tolerated and could be a promising method to enhance mobility in stroke survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of transcutaneous spinal cord stimulation (tSCS) with robot-assisted gait training for stroke survivors because it offers a novel approach to rehabilitation. Unlike traditional physical therapy, which primarily focuses on retraining muscles, tSCS delivers electrical stimulation to the spinal cord, potentially enhancing neural pathways and improving motor function. This innovative method could lead to more significant improvements in walking ability compared to standard gait training alone, providing new hope for stroke recovery.

What evidence suggests that this trial's treatments could be effective for stroke survivors?

Research has shown that transcutaneous spinal cord stimulation (tSCS) can enhance movement in stroke survivors. In this trial, some participants will receive robot-assisted gait training with tSCS, while others will receive only robot-assisted gait training. Studies have found that combining tSCS with robot-assisted walking exercises can ease walking. This combination helps stroke survivors move their legs more effectively and feel more stable when walking. The treatment is safe and effective, particularly when used alongside other rehabilitation methods. Overall, tSCS offers a promising approach to improving mobility in stroke survivors. ^{2 3 4 6 7}

Who Is on the Research Team?

Wen Liu, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for chronic stroke survivors who cannot walk. It's designed to test if a combination of robot-assisted walking exercises and spinal cord stimulation can help improve their mobility.

Inclusion Criteria

Able to communicate with investigators, follow 2-step command, and correctly answer consent comprehension questions in English

Currently not participating in treadmill walking exercises or exercises involving weight-bearing activities

Have physicians' approval for exercise and be in a stable medical condition

Exclusion Criteria

Blood pressure higher than 200/110 mm Hg

Contraindications to tSCS and TMS

I have a condition that stops me from doing physical exercises.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive robot-assisted gait training and transcutaneous spinal cord stimulation

8 weeks

24 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Cord Stimulation

Trial Overview The study compares two approaches: one group receives both robot-assisted gait training and transcutaneous spinal cord stimulation (tSCS), while the other group gets only the robot-assisted training. The goal is to see which method helps more with walking.

How Is the Trial Designed?

Group I: Robot assisted gait training combined with Transcutaneous spinal cord stimulation Experimental Treatment 1 Intervention

Group II: Robot assisted gait training alone Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Effectiveness of Transcutaneous Spinal Cord Stimulation for ... The primary outcome will be lower limb motor function assessed by validated measures such as the Lower Extremity Motor Score. Secondary outcomes ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... This study showed that tSCS combined with ABT is safe, feasible, and effective in adults with chronic SCI ranging from the cervical to thoracic level when ...

3. biomedical-engineering-online.biomedcentral.com biomedical-engineering-online.biomedcentral.com/articles/10.1186/s12938-024-01231-1

Noninvasive spinal stimulation improves walking in chronic ... This case series study aims to investigate the effectiveness of transcutaneous spinal cord stimulation (tSCS) in enhancing walking ability of persons with ...

4. research.aota.org research.aota.org/ajot/article/78/2/7802180220/25157/Spinal-Cord-Stimulation-for-Poststroke-Hemiparesis

Spinal Cord Stimulation for Poststroke Hemiparesis The results of this study show that spinal cord stimulation may provide an alternative way to improve motor function after stroke.

5. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ... Enhanced trunk control and stability (9), improved lower extremity (LE) function, locomotor output, and standing (6, 8, 13) as well as reduced ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014404/

Cardiovascular safety of transcutaneous spinal cord ... Sessions of tSCS ​+ ​rehab did not cause significant changes in blood pressure or heart rate compared to Rehab alone (p ​> ​0.05). Further, ...

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000205724

Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy ... Clinic and home-based ARC EX Therapy is safe and effectively improves upper extremity strength and function in people living with chronic, cervical SCI.