Restoring cortical control of functional movement in a human with quadriplegia.
Chad E Bouton, Ammar Shaikhouni, Nicholas V Annetta...
https://pubmed.ncbi.nlm.nih.gov/27074513Actively Recruiting
Early Phase 1
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID04755699
Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
Led by Northwell Health · Updated on 2026-03-11
64
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device can improve arm and hand movements in people with paralysis or weakness caused by spinal cord injury, stroke, or other brain or nerve injuries. This early feasibility trial aims to study functional improvements in both upper and lower limbs depending on the type of injury. Participants will attend up to 5 study sessions per week for up to one year, with each session lasting as long as 4 hours. During sessions, the study team will manually map and then deliver electrical stimulation to muscles and/or the spinal column to evoke specific limb movements. Electroconductive gels or hydrogels will be used to assist electrode placement. The study includes four groups: healthy volunteers and individuals with spinal cord injury, stroke, or other brain or nerve injuries, all receiving stimulation targeted to improve movement. At the first session, demographic information and vital signs will be collected, along with baseline clinical evaluations of movement and sensation. Throughout the study, participants will perform tasks designed to improve movement, with assessments using visual inspection, electromyography, motion tracking, and various validated clinical tests to measure functional changes. Participation ends after the last session when functional improvements are evaluated against baseline. The primary outcome is device feasibility for changing muscle activation over 12 months.
CONDITIONS
Brief Title
Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
Who Can Participate
Age: 18Years - 75Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 to 75 years
- Healthy volunteers without physical disabilities or conditions that prevent completing study tasks or increase risk
- Individuals with limited ability to use at least one hand due to spinal cord injury or stroke, at least 6 months after stroke or 1 year after spinal cord injury
- Individuals with limited or no ability to use at least one limb due to brain or nerve injury such as traumatic brain injury, brachial plexus injury, peripheral nerve damage, or Parkinson's Disease
- English proficiency sufficient to follow verbal commands and provide informed consent
- Willingness and ability to attend up to 5 study sessions per week for up to 1 year, with sessions lasting up to 4 hours each
You will not qualify if you...
- Participation in another study that could affect this study's conduct or results
- Stage III-IV pressure ulcers interfering with study involvement
- History of epilepsy
- Chronically implanted electronic medical devices (e.g., pacemaker, deep brain stimulator)
- Abnormalities preventing electrical stimulation of limbs or spinal column
- Ventilator dependence
- History of serious mood or thought disorders
- Uncontrolled autonomic dysreflexia
- Severe spasticity in target limbs uncontrolled by medication or preventing stimulation
- Botulinum toxin injections to target limbs within 3 months
- Active cancer near stimulation areas
- History of heart or kidney disease
- Additional neurologic diseases like multiple strokes or multiple sclerosis
- Serious infections or disorders affecting participation (e.g., uncontrolled hypertension, diabetes, rheumatic disease, peripheral neuropathy, HIV/AIDS)
- Substance abuse problems
- Pregnancy
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 12 months
Participants receive transcutaneous electrical stimulation to muscles and/or spinal column to evoke specific limb movements. Mapping sessions are conducted to determine optimal electrode placement using electroconductive gels and hydrogels. Functional movement is assessed through clinical tests and sensors.
Up to 5 sessions per week, each lasting up to 4 hours
Trial Site Locations
Total: 1 location
1
Northwell Health's The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Actively Recruiting
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Research Team
E
Erona Ibroci, MPH
C
Chad E Bouton, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
4
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Nikunj Bhagat, Kevin King, Richard Ramdeo...
https://pubmed.ncbi.nlm.nih.gov/32864392