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Procedure

Noninvasive Spinal Stimulation for Stroke Recovery

N/A
Recruiting
Led By Arun Jayaraman, PT, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support of one person to help with balance and coordination
Not currently receiving regular physical therapy services
Timeline
Screening 3 weeks
Treatment Varies
Follow Up aim 1: baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. aim 2: baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.
Awards & highlights

Study Summary

This trial will study if a non-invasive spinal cord stimulator can help improve gait and balance for people with hemiplegia caused by stroke.

Who is the study for?
This trial is for adults over 18 who have hemiplegia from a stroke at least 6 months ago and need some help walking. They shouldn't be getting regular physical therapy, must have doctor's approval to join, and can't be pregnant or nursing. People with seizures unrelated to stroke, certain neurological conditions, severe muscle tightness in legs, recent Botox in the leg, metal implants in head/face or using heart devices like pacemakers are excluded.Check my eligibility
What is being tested?
The study tests if non-invasive spinal cord stimulation improves walking and balance in people with hemiplegia after a stroke. It has two parts: one where participants try different methods one after another (cross-over), and another where they're randomly assigned to either get the real treatment or a pretend (sham) version.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, skin irritation from electrode placement, fatigue due to gait training exercises, mild headaches or dizziness immediately following stimulation sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need someone's help to walk because of balance or coordination issues.
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I am not currently undergoing regular physical therapy.
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I am 18 years old or older.
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I have paralysis on one side of my body due to a stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~aim 1: baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. aim 2: baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.
This trial's timeline: 3 weeks for screening, Varies for treatment, and aim 1: baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. aim 2: baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Gait Symmetry
Secondary outcome measures
Change in 10 Meter Walk Test
Change in 6 Minute Walk Test

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Aim 2: Gait Training + StimulationExperimental Treatment2 Interventions
Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
Group II: Aim 1: Gait Training + StimulationExperimental Treatment2 Interventions
Up to 60 min of locomotion training with transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
Group III: Aim 1: Stimulation OnlyActive Control2 Interventions
Up to 60 minutes of transcutaneous spinal cord stimulation while resting in a comfortable position.
Group IV: Aim 1: Gait Training + Sham StimulationActive Control2 Interventions
Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
Group V: Aim 2: Gait Training + Sham StimulationActive Control2 Interventions
Up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention while performing locomotion training. However, the amount of time spent in side-lying locomotion training, treadmill training and over ground training will depend on individual tolerance and progression.
Group VI: Aim 1: Sham OnlyPlacebo Group2 Interventions
Up to 60 minutes of transcutaneous spinal cord stimulation while resting in a comfortable position during which they will receive up to 30 seconds of transcutaneous spinal cord stimulation in order to blind them to the intervention.

Find a Location

Who is running the clinical trial?

University of California, Los AngelesOTHER
1,530 Previous Clinical Trials
10,278,087 Total Patients Enrolled
34 Trials studying Stroke
6,255 Patients Enrolled for Stroke
Shirley Ryan AbilityLabLead Sponsor
194 Previous Clinical Trials
16,797 Total Patients Enrolled
70 Trials studying Stroke
8,230 Patients Enrolled for Stroke
Arun Jayaraman, PT, PhDPrincipal InvestigatorShirley Ryan AbilityLab
22 Previous Clinical Trials
2,787 Total Patients Enrolled
9 Trials studying Stroke
1,437 Patients Enrolled for Stroke

Media Library

Conventional gait training (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05167786 — N/A
Stroke Research Study Groups: Aim 1: Stimulation Only, Aim 1: Gait Training + Stimulation, Aim 1: Gait Training + Sham Stimulation, Aim 1: Sham Only, Aim 2: Gait Training + Stimulation, Aim 2: Gait Training + Sham Stimulation
Stroke Clinical Trial 2023: Conventional gait training Highlights & Side Effects. Trial Name: NCT05167786 — N/A
Conventional gait training (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05167786 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for new participants in this research?

"Yes, this is an active trial that has been posted since March 1st, 2022 and was edited recently on September 9th. They are looking for 115 individuals to participate at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
65+
What site did they apply to?
Shirley Ryan AbilityLab
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Arun Jayaraman, PT, PhD 2022. "Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05167786.
~61 spots leftby Aug 2026
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