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Non-invasive Cervical Electrical Stimulation for SCI

NCT03414424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-11-29

Study results available
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Summary

Most spinal cord injuries (SCI) are anatomically incomplete - some nerve circuits remain intact, even if the individual cannot feel or control them. Activating spared nerve circuits may improve functional recovery.

With this goal, the Investigators have developed a form of electrical stimulation over the cervical spinal cord that can activate muscles in both hands simultaneously and comfortably. This technique, called cervical electrical stimulation (CES), works at the skin surface - no surgery or other invasive procedures are required.

The long-term goal is to use CES to strengthen residual circuits to hand muscles after SCI. Regaining control over hand function represents the top priority for individuals with cervical SCI.

In the current study, the Investigators first need to better understand how CES works. In the first half of this study, the Investigators will take a systematic approach to determining how CES interacts with other circuits in the spinal cord and the brain. In the second half of the study, the Investigators will test combinations of CES with active hand and wrist movements to find ways to enhance physical movement with CES.

These experiments will improve understanding of electrical stimulation in SCI, and may set the table for future treatments to prolong any short-term benefits observed in this study.

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

CES at rest

CES will be delivered at rest at various intensities, in combination with either electrical stimulation over peripheral nerves or magnetic stimulation over the motor cortex. This is an experiment designed to measure CES interactions with other central and peripheral nerve circuits.

DEVICE

CES plus active hand or wrist movements

CES will be delivered while the participant performs specific finger or wrist tasks at different degrees of effort. This is an experiment designed to detect momentary changes in muscle function.

Sponsors & Collaborators

  • Bronx VA Medical Center

    lead FED

Principal Investigators

  • Noam Y. Harel, MD, PhD · Bronx VA Medical Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2017-08-22
Primary Completion
2021-04-30
Completion
2021-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03414424 on ClinicalTrials.gov