The Biophysical Impact of Transcutaneous Spinal Cord Stimulation Within a Single Session (TSCS)

February 26, 2018 updated by: Rebecca Martin, OTR/L, OTD, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
To determine the biophysical impact of biophysical Impact of Transcutaneous Spinal Cord Stimulation (TSCS) within a single session. We hypothesize that subjects will demonstrate increased volitional muscle strength with TSCS. This will be assessed by isokinetic strength testing of post-injury dominant-side knee extension. Subjects will be tested in both Transcutaneous Spinal Cord Stimulation and sham conditions.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct isokinetic strength testing (via the Biodex) of post-injury, dominant-side knee extension before, during, and after TSCS and a sham condition. Transcutaneous Spinal Cord Stimulation will be applied (via the Vectra Neo) using a 5cm x10cm oval electrode placed midline on the skin between spinous process T11 -T12 as a cathode and two 7.5cm x 13cm rectangular electrodes placed symmetrically on the skin over the lower abdomen as anodes. A symmetrical biphasic rectangular waveform, at 50Hz and 1millisecond, will be used to provide 30 continuous minutes of stimulation. As sham procedures for this intervention have not been established, the investigators will follow sham procedures well documented in Transcranial DC Stimulation (tDCS). Electrodes will be placed as they are in the Transcutaneous Spinal Cord Stimulation condition. Stimulation will be applied at subject's maximum intensity for 30 seconds and then discontinued. Subjects will participate in two testing sessions, each approximately one hour in length, separated by at least 24 hours.

Subject's starting condition will be randomized. Subjects will be informed that two stimulation conditions are being tested, but will not be told which is the experimental condition.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Rebecca Martin, OTR/L, OTD, CPAM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • > 1 year post spinal cord injury
  • Non-progressive spinal cord injury
  • Neurological level above T10
  • Tolerates upright position for >30 minutes
  • Medically stable (no hospitalizations in last 3 months)
  • Unilateral knee extension strength >/= 1/5 MMT
  • Able to comply with procedures and follow up
  • Are legally able to make their own health care decisions

Exclusion Criteria:

  • Progressive SCI/D (MS, ALS, ADEM, etc.)
  • Opens wounds at stimulation site
  • Pregnant women
  • ROM limits of >10 degree of knee flexion or extension
  • Cardiac pacemaker/defibrillator
  • Active cancer diagnosis
  • Currently receiving TSCS
  • Evidence of uncontrolled autonomic dysreflexia
  • Non- English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous Spinal Cord Stimulation
Subjects will participate in a single session of Transcutaneous Spinal Cord Stimulation, involving 30 minutes of stimulation with isokinetic strength testing of knee extension.
Other: Transcutaneous Spinal Cord Stimulation
Transcutaneous Spinal Cord Stimulation is a non-invasive mechanism to enhance excitation of spinal neural circuitry and represents a promising supplement to existing physical therapy programs. Transcutaneous Spinal Cord Stimulation will be applied (via the Vectra Neo) using a 5cm x10cm oval electrode placed midline on the skin between spinous process T11 -T12 as a cathode and two 7.5cm x 13cm rectangular electrodes placed symmetrically on the skin over the lower abdomen as anodes.7,9 A symmetrical biphasic rectangular waveform, at 50Hz and 1millisecond, will be used to provide 30 continuous minutes of stimulation.
Other Names:
  • TSCS
Sham Comparator: Sham
Subjects will participate in a single session of isokinetic strength testing of knee extension with sham stimulation.
Other: Sham stimulation
Sham procedures, well documented in Transcranial DC Stimulation (tDCS), will be used. Electrodes will be placed as they are in the Transcutaneous Spinal Cord Stimulation condition. Stimulation will be applied at subject's maximum intensity for 30 seconds and then discontinued.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee extension strength
Time Frame: Day 1, Day 2
Change in isokinetic strength assessment of the post-injury dominant side quadripceps
Day 1, Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Investigators

  • Principal Investigator: Rebecca Martin, OTR/L, OTD, CPAM, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00103592

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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