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Brain and Nerve Stimulation for Hand Muscles in Spinal Cord Injury and ALS

NCT02469675 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2018-10-01

No results posted yet for this study

Summary

Most neurological injuries such as spinal cord injuries (SCI) and amyotrophic lateral sclerosis (ALS) spare a portion of nerve circuitry. Strengthening spared nerve circuits may be an important method to improve functional recovery.

In this study, the investigators aim to use non-invasive magnetic and electrical stimulation to strengthen motor circuits between the brain and hands. Magnetic stimulation will be used over the motor cortex (scalp). Two methods of electrical stimulation will be compared: stimulation of the median nerve at the wrist; or direct stimulation of the cervical spinal cord across the skin on the back of the neck. Several different combinations of magnetic and electrical stimulation will be compared to find the conditions that best strengthen nerve circuits between the brain and hands - "Fire Together, Wire Together".

PLEASE NOTE, THIS IS A PRELIMINARY STUDY. This study is testing for temporary changes in nerve transmission and hand function. THERE IS NO EXPECTATION OF LONG-TERM BENEFIT FROM THIS STUDY. If we see temporary changes in this study, then future studies would focus on how to prolong that effect.

Conditions

  • Spinal Cord Injury (SCI)
  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DEVICE

Transcranial magnetic stimulation

One TMS pulse every 10 seconds for 20 minutes

DEVICE

Median nerve stimulation

One median nerve pulse every 10 seconds for 20 minutes

DEVICE

Cervical transcutaneous stimulation

One cervical pulse every 10 seconds for 20 minutes

Sponsors & Collaborators

  • Bronx VA Medical Center

    lead FED

Principal Investigators

  • Noam Y. Harel, MD, PhD · James J. Peters VA Medical Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-07-31
Completion
2018-07-31
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 NCT02469675 on ClinicalTrials.gov