RECRUITING

Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device improves functional arm/hand movements in individuals with paralysis or paresis due to a spinal cord injury or stroke and improves functional arm/hand or leg/foot movements in individuals with paralysis or paresis due to other brain or nerve injuries. In this study, eligible individuals that agree to participate will be asked to attend up to 5 study sessions a week for 1 year (depending on participant availability), with each session lasting up to 4 hours. At the first study session, participants will have their demographic information collected, vital signs assessed, and have measurements performed of their limbs and torso, as appropriate. They will also undergo clinical evaluations and tests to assess their current functional movement and sensation capabilities. During subsequent study sessions, participants will undergo many tasks designed to improve functional movements in paralyzed limbs. Specifically, participants will receive neuromuscular electrical stimulation to the limb(s) and/or electrical stimulation to the spinal cord to evoke specified movements. The stimulation parameters and locations on the spinal column and/or limb(s) that evoke specific movements will be noted. The movements will be assessed with visual inspection, electromyography, and/or sensors. The clinical evaluations and tests to assess functional movement and sensation capabilities will be repeated throughout the study and at the last study session to assess for functional improvements compared to the first study session. Upon completion of these study sessions, the individual's participation in the study is considered complete.

Official Title

Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis

Quick Facts

Study Start:2020-12-02
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04755699

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals between 18 and 75 years of age
  2. * Individuals without physical disabilities or conditions/diseases that may make them incapable of completing the physical study tasks or otherwise places them at a greater risk of harm
  3. * Individuals that are considered English Proficient due to the study requirements to follow verbal commands during sessions
  4. * Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation
  5. * Individuals that are willing and able to visit the study center for study procedures, which may be up to 5 sessions a week for up to 1 year (at least 2 months) at up to 4 hours per session
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Erona Ibroci, MPH
CONTACT
516-562-3634
eibroci@northwell.edu
Chad E Bouton, MS
CONTACT
516-562-3457
cbouton@northwell.edu

Principal Investigator

Chad E Bouton, MS
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

Northwell Health's The Feinstein Institute for Medical Research
Manhasset, New York, 11030
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • Chad E Bouton, MS, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-02
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2020-12-02
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Neuromuscular Stimulation
  • Spinal Cord Stimulation
  • Physical Medicine and Rehabilitation

Additional Relevant MeSH Terms

  • Healthy Volunteers
  • Spinal Cord Injury
  • Stroke
  • Paralysis
  • Paresis
  • Neurological Injury