Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Neurological Injury
- Paralysis
- Paresis
- Spinal Cord Injury
- Stroke
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study will enroll a total of 28 participants. Of the 28 participants, 7 will be healthy volunteers having no disabilities, 7 will be individuals with paralysis or paresis from a spinal cord injury, 7 will be individuals with paralysis or paresis from a stroke, and 7 will be individuals with paralysis or paresis from other brain or nerve injuries.Masking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
During study sessions, both neuromuscular and spinal cord stimulation will first be manually administered to properly map the area in relation to intended movements. Once mapping for placement is completed, the study team will proceed with administering electrical stimulation with the investigationa...
During study sessions, both neuromuscular and spinal cord stimulation will first be manually administered to properly map the area in relation to intended movements. Once mapping for placement is completed, the study team will proceed with administering electrical stimulation with the investigational stimulator to evoke specific movements. In order to facilitate the connectivity of these electrodes with the skin, electroconductive gels, lotions, creams, and sold hydrogels may be used. The improvement of the precision, specificity, and extent of functional movements over the course of focused electrical stimulation sessions for various electrical stimulation amplitudes at key locations will be assessed visually and through electromyography. The grip strength and evoked pressures at the limbs will also be measured using sensors placed at those locations. The specificity and quantification of the various movements will be assessed with a motion tracking device as well. The study will use the following clinical tests and graded tasks, as needed, to assess changes in functional movement over time: Range of Movement Evaluation; Spasticity Reduction Evaluation; Sensory Perception Evaluation; Graded Redefined Assessment of Strength, Sensibility, and Prehension; Jebsen-Taylor Test; Action Research Arm Test; Chedoke Arm and Hand Activity Inventory; Chedoke-McMaster Stroke Scale; Wolf Motor Function Test; Just Noticeable Weight Test; Grip Strength / Finger Strength Assessments; Fugl-Meyer Assessment; Stroke Rehabilitation Assessment of Movement; and Object Transfer Tests (including 9-Hole Peg & Cup/Cone/Ball Transfer). All of these tests and exams have been validated, and involve participants performing simple movement tasks or identifying a physical sensation.
Tracking Information
- NCT #
- NCT04755699
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Chad E Bouton, MS Northwell Health