Evaluating Neuromuscular Stimulation for Restoring Hand Movements

Early Phase 1

Completed

• Conditions: Healthy Volunteers; Physical and Rehabilitation Medicine; Spinal Cord Injury Cervical
• Interventions: Device: Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.

• Registration Number: NCT03385005
• Lead Sponsor: Northwell Health

Brief Summary

The specific aim of this study is to evoke functional movement in the hand of both healthy individuals and individuals diagnosed with a stable cervical spinal cord injury with non-functional movement of the fingers. The primary purpose of this study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm. It is believed that this study will be able to identify specific stimulation parameters and electrode spatial configurations responsible for various refined hand movements.

After an eligible individual agrees to participate in this study, s/he will receive transcutaneous electrical stimulation on the forearm in order to evoke different hand and finger movements. The precision, specificity, and extent of these movements will be visually assessed. In order to better evaluate these movements, participants may also be asked to perform various functional tasks with their hand. The grip strength and evoked forces at the fingertips will also be measured using sensors. There will be up to 4 study sessions each week for up to 8 weeks, with each session lasting up to 4 hours. Upon completion of these study sessions, the individual's participation in the study is considered complete.

Detailed 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 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.

Study Timeline

• Study Start: 2017-09-15
• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2017-12-28
• Primary Completion: 2020-12-07
• Status Verified: 2023-10
• Study Completion: 2023-10-01
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Spinal Cord Injury Participants	Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.	This arm consists of spinal cord injury participants receiving electrical stimulation of the muscles within the forearm via an investigational (not FDA approved) neuromuscular stimulator.
Healthy Volunteers	Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.	This arm consists of healthy volunteers receiving electrical stimulation of the muscles within the forearm via an investigational (not FDA approved) neuromuscular stimulator.

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm, as assessed by force sensors.	This outcome measure will be assessed at each study session throughout the 8-week duration of the study.	The primary outcome measure will be achievable wrist and finger movements that will be assessed by the exerted force (measured in Newtons by force sensors on the fingers and palm) in each of the flexion, extension, adduction, abduction, pronation, or supination movements. This will provide the magnitude of the movement in relation to the stimulation parameters and electrode spatial configurations.
The primary outcome of the study is to determine the feasibility of achieving refined hand movements through electrical stimulation of the muscles within the forearm, as assessed by visual inspection.	This outcome measure will be assessed at each study session throughout the 8-week duration of the study.	The primary outcome measure will be achievable wrist and finger movements that will be visually assessed for the type and extent of motion in relation to the stimulation parameters and electrode spatial configurations. The extent of wrist, forearm, and individual finger movements will be categorized as either flexion, extension, adduction, abduction, pronation, or supination and graded as no movement, slight movement, moderate movement, or substantial movement.

Trial Locations

Locations (1)

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