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

Primary Purpose

Spinal Cord Injuries

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Spinal Cord Stimulation
Sham stimulation
Sponsored by
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rebecca Martin, OTR/L, OTD, CPAM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcutaneous Spinal Cord Stimulation

Sham

Arm Description

Subjects will participate in a single session of Transcutaneous Spinal Cord Stimulation, involving 30 minutes of stimulation with isokinetic strength testing of knee extension.

Subjects will participate in a single session of isokinetic strength testing of knee extension with sham stimulation.

Outcomes

Primary Outcome Measures

Knee extension strength
Change in isokinetic strength assessment of the post-injury dominant side quadripceps

Secondary Outcome Measures

Full Information

First Posted
February 2, 2017
Last Updated
February 26, 2018
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03046875
Brief Title
The Biophysical Impact of Transcutaneous Spinal Cord Stimulation Within a Single Session
Acronym
TSCS
Official Title
The Biophysical Impact of Transcutaneous Spinal Cord Stimulation Within a Single Session
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The study was never initiated because of lack of funding and research priorities have been shifted elsewhere.
Study Start Date
October 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous Spinal Cord Stimulation
Arm Type
Experimental
Arm Description
Subjects will participate in a single session of Transcutaneous Spinal Cord Stimulation, involving 30 minutes of stimulation with isokinetic strength testing of knee extension.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Subjects will participate in a single session of isokinetic strength testing of knee extension with sham stimulation.
Intervention Type
Other
Intervention Name(s)
Transcutaneous Spinal Cord Stimulation
Other Intervention Name(s)
TSCS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Knee extension strength
Description
Change in isokinetic strength assessment of the post-injury dominant side quadripceps
Time Frame
Day 1, Day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Martin, OTR/L, OTD, CPAM
Organizational Affiliation
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rebecca Martin, OTR/L, OTD, CPAM
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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