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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

Must not have

Active urinary tract infection

Traumatic brain injury or other neurological conditions that would impact the study

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have a urinary tract infection.

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I do not have a brain injury or neurological condition affecting the study.

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I have pain in my muscles or joints due to recent injuries or infections.

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I have a medical condition that makes it hard for me to walk.

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I have a bone fracture that has not yet healed.

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I do not have uncontrolled heart, lung, or metabolic conditions.

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I have severe stiffness in my legs that limits movement.

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I have nerve damage in my hands or feet.

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I have active pressure sores.

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I have a leg condition that affects my ability to walk or move.

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My cancer is active or has been in remission for less than 5 years.

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I have metal implants in my head or face.

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I have had more than one stroke.

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I have had skull abnormalities or fractures.

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I have had seizures not caused by a stroke, or I have epilepsy.

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I have difficulty coordinating my movements.

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My leg stiffness is severe, scoring 3 or more.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Gait Symmetry

Secondary study objectives

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

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

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.

0 / 21Eligibility criteria met