Your session is about to expire
← Back to Search
Other
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 belowSelect...
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
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
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
475 Previous Clinical Trials
469,256 Total Patients Enrolled
2 Trials studying Paralysis
76 Patients Enrolled for Paralysis
Chad E Bouton, MSPrincipal InvestigatorNorthwell Health
2 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe pressure ulcers, epilepsy, implanted devices, or other listed conditions.I am 18-75, healthy, understand English, and can visit the study center.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.I am 18-75, had a stroke or spinal cord injury over a year ago, and struggle to use one hand.
Research Study Groups:
This trial has the following groups:- Group 1: Individuals with a Spinal Cord Injury
- Group 2: Individuals with a Stroke
- Group 3: Individuals with other Brain or Nerve Injuries
- Group 4: Healthy Volunteers
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.