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Electrical Stimulation for Paralysis/Paresis

Phase < 1

Recruiting

Led By Chad E Bouton, MS

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Brain or Nerve Injury Participant: Individuals between 18 and 75 years of age with a limited ability or no ability to use at least one limb due to a brain or nerve injury, considered English Proficient, able to comprehend the study goals and procedures, willing and able to visit the study center for study procedures

Stroke and Spinal Cord Injury Participant: Individuals between 18 and 75 years of age with a limited ability or no ability to use at least one hand due to a spinal cord injury or stroke, at least one year from their initial stroke or spinal cord injury, considered English Proficient, able to comprehend the study goals and procedures, willing and able to visit the study center for study procedures

Timeline

Screening 1 day

Treatment 3 months

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is to study whether electrical stimulations to the limb(s) and/or spinal cord can help improve functional movements in people with paralysis or paresis due to a spinal cord injury or stroke.

Who is the study for?

This trial is for individuals aged 18-75 with paralysis or paresis due to spinal cord injury, stroke, or other brain/nerve injuries. Healthy volunteers without physical disabilities are also eligible. Participants must be English proficient, able to understand the study, and commit to frequent visits over a year.

What is being tested?

The trial tests if transcutaneous electrical stimulation improves arm/hand and leg/foot function in paralyzed or weakened limbs. It involves up to five sessions per week for one year with tasks designed to enhance movement through neuromuscular and spinal cord stimulation.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, muscle fatigue from repeated movements during sessions, skin irritation from electrodes used for electrical stimulation, and possible exacerbation of existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18-75, with a limb I can't use well due to brain or nerve injury, speak English, and can visit the study center.

Select...

I am 18-75, had a stroke or spinal cord injury over a year ago, and struggle to use one hand.

Timeline

Screening ~ 1 day1 visit

Treatment ~ 3 months0 visits

Follow Up ~ 12 months

Screening ~ 1 day

Treatment ~ 3 months

Follow Up ~12 months

This trial's timeline: 1 day for screening, 3 months for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Device Feasibility for Changing Muscle Activation of the Arm and Hand

Other study objectives

Change in Muscle Activation of the Targeted Limbs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Individuals with other Brain or Nerve InjuriesExperimental Treatment1 Intervention

This arm consists of individuals with a other brain and nerve injuries receiving transcutaneous electrical stimulation to the arms/hand, legs/foot, and/or spinal column to evoke various arm/hand or leg/foot movements.

Group II: Individuals with a StrokeExperimental Treatment1 Intervention

This arm consists of individuals with a stroke receiving transcutaneous electrical stimulation to the arms/hand and/or spinal column to evoke various arm/hand movements.

Group III: Individuals with a Spinal Cord InjuryExperimental Treatment1 Intervention

This arm consists of individuals with a spinal cord injury receiving transcutaneous electrical stimulation to the arms/hand and/or spinal column to evoke various arm/hand movements.

Group IV: Healthy VolunteersActive Control1 Intervention

This arm consists of healthy volunteers receiving transcutaneous electrical stimulation to the arms, legs, and/or spinal column to evoke various arm/hand and leg/foot movements.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous Electrical Stimulation

2023

N/A

~40

0 / 2Eligibility criteria met