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

Part of paid clinical trials in Manhasset, New York.

Sponsor
Northwell Health
Study ID
NCT04755699
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Transcutaneous Electrical Stimulation — DEVICE
    The study involves the administration of various electrical pulses being delivered to muscles and/or the spinal column with an investigational neurostimulator to evoke various limb movements in order to improve functional movement.

Study Details

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.

Key Dates

Start date
Dec 2, 2020
Status verified
Jun 2025
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Active Comparator: Healthy Volunteers
    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.
  • Experimental: Individuals with a Spinal Cord Injury
    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.
  • Experimental: Individuals with a Stroke
    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.
  • Experimental: Individuals with other Brain or Nerve Injuries
    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.

Primary Outcome Measure

Device Feasibility for Changing Muscle Activation of the Arm and Hand [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell Health's The Feinstein Institute for Medical ResearchManhassetNew York11030
Erona Ibroci, MPH
[email protected]
516-562-3634

Find similar trials in Manhasset, NY

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Northwell Health's The Feinstein Institute for Medical Research· Manhasset, NY

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