Evaluating Neuromuscular Stimulation for Restoring Hand Movements
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 15
Summary
- Conditions
- Healthy Volunteers
- Physical and Rehabilitation Medicine
- Spinal Cord Injury Cervical
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The study will involve 3-10 eligible healthy volunteers and 2-5 eligible individuals with a stable cervical spinal cord injury. The study will first enroll healthy volunteers into the study in order to determine the feasibility of evoking refined hand movements through electrical stimulation, and determine the electrical stimulation parameters and electrode spatial configurations responsible for various hand movements. After this is done, the study will proceed with the enrollment of individuals with spinal cord injuries. This enrollment process is being done to reduce the participation time required for participants with a spinal cord injury, and thus lower the likelihood of risks that are more prevalent among individuals with a spinal cord injury.Masking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
In order to evaluate whether electrical stimulation applied to the muscles within the forearm can evoke functional movement in the hand, participants will receive transcutaneous electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator. Participants will be asked to a...
In order to evaluate whether electrical stimulation applied to the muscles within the forearm can evoke functional movement in the hand, participants will receive transcutaneous electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator. Participants will be asked to attend up to 4 study sessions a week for up to 8 weeks, with each session lasting up to 4 hours. At these sessions, electrical pulses will be sent to the forearm muscles through electrodes placed on the skin. These electrodes may also be accompanied with a gel or lotion to allow for a better connection of the electrodes to the skin. The precision, specificity, and extent of hand and finger movements will be visually assessed in real time and later reassessed on video recordings of the session. The study will also involve the placement of sensors on the hand and finger to measure the amount of grip strength and evoked forces. In order to monitor the health of participants, the study will assess blood pressure and heart rate before, during, and after the electrical stimulation. Upon completion of these study sessions, the individual's participation in the study is considered complete.
Tracking Information
- NCT #
- NCT03385005
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Chad E Bouton, MS Northwell Health
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