MedTrace Logo

Evaluating Neuromuscular Stimulation for Restoring Hand Movements

NCT03385005 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-10-10

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers
  • Spinal Cord Injury Cervical
  • Physical and Rehabilitation Medicine

Interventions

DEVICE

Participants will receive neuromuscular electrical stimulation via an investigational (not FDA approved) neuromuscular stimulator.

The study involves the administration of various electrical pulses being delivered to muscles of the forearm from a neuromuscular stimulator in order to evoke different hand and finger movements. The grip strength and evoked forces at the fingertips will also be measured using sensors.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Chad E Bouton, MS · Northwell Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2020-12-07
Completion
2023-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03385005 on ClinicalTrials.gov