Early Phase 1 Stroke Trial, Recruiting NCT04755699 Sponsor: Northwell Health Condition: Stroke
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Early Phase 1 Stroke Trial, Recruiting

NCT04755699
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Healthy volunteers:

  • Adults between 18 and 75 years of age who do not have a physical disability or health condition that would prevent them from completing physical tasks in the study
  • People who are proficient in English, as the study requires following spoken instructions during sessions
  • People who are able to understand the study's goals and procedures and can give their informed consent to take part
  • People who are able to visit the study centre up to 5 times per week, for sessions of up to 4 hours, for a period of at least 2 months and up to 1 year

People who have had a stroke or spinal cord injury:

  • Adults between 18 and 75 years of age who have limited use of at least one hand as a result of a stroke or spinal cord injury
  • People who are at least 6 months past their stroke, or at least 1 year past their spinal cord injury
  • People who are proficient in English, as the study requires following spoken instructions during sessions
  • People who are able to understand the study's goals and procedures and can give their informed consent to take part
  • People who are able to visit the study centre up to 5 times per week, for sessions of up to 4 hours, for a period of at least 2 months and up to 1 year

People who have had a brain or nerve injury:

  • Adults between 18 and 75 years of age who have limited or no use of at least one limb due to a brain or nerve injury — such as a traumatic brain injury, brachial plexus injury, peripheral nerve damage, or Parkinson's Disease
  • People who are proficient in English, as the study requires following spoken instructions during sessions
  • People who are able to understand the study's goals and procedures and can give their informed consent to take part
  • People who are able to visit the study centre up to 5 times per week, for sessions of up to 4 hours, for a period of at least 2 months and up to 1 year

Who may not be able to join:

  • People who are currently taking part in another study that could affect this study's procedures or results
  • People who have severe pressure sores (Stage III–IV) that would interfere with their involvement in the study, such as sores on the limb being studied or that prevent sitting for extended periods
  • People with a history of epilepsy
  • People who have a permanently implanted electronic medical device, such as a deep brain stimulator, heart pacemaker, spinal stimulator, or vagus nerve stimulator
  • People who have physical differences in their arms, hands, legs, feet, or spine that would prevent electrical stimulation from being applied safely
  • People who rely on a ventilator to breathe
  • People with a history of serious mood or thought disorders
  • People with uncontrolled autonomic dysreflexia (a condition involving sudden changes in the nervous system — confirm with trial site)
  • People with severe muscle stiffness or spasms in the limb being studied that cannot be managed with medication or that prevents electrical stimulation
  • People who have received Botulinum toxin (e.g. Botox) injections in the limb being studied within the past 3 months
  • People who have active cancer at or near the area where electrical stimulation would be applied
  • People with a history of heart or kidney disease
  • People with a history of additional neurological conditions, such as multiple sclerosis or multiple strokes
  • People with other serious health conditions that could affect their ability to participate, such as uncontrolled high blood pressure, uncontrolled diabetes, rheumatic disease, peripheral neuropathy, or HIV/AIDS
  • People with a substance abuse problem, including alcohol
  • People who are pregnant
  • People who are currently imprisoned

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Chad E Bouton, MS, Northwell Health

Phone: 516-562-3634

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Northwell Health
Registry
ClinicalTrials.gov
Start date
2 December 2020
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Device Feasibility for Changing Muscle Activation of the Arm and Hand

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov