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

NCT03046875 | Withdrawn DMC

• 1 other identifier: IRB00103592
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Knee extension strength

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

  Day 1, Day 2

Study Arms (2)

Transcutaneous Spinal Cord Stimulation

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Other: Sham stimulation

Interventions

Transcutaneous Spinal Cord Stimulation OTHER

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.

Also known as: TSCS

Transcutaneous Spinal Cord Stimulation

Sham stimulation OTHER

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.

Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead

Study Sites (1)

Rebecca Martin, OTR/L, OTD, CPAM

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Rebecca Martin, OTR/L, OTD, CPAM

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager Clinical Education and Training, International Center for Spinal Cord Injury Assistant Professor, Johns Hopkins School of Medicine, Dept. of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 8, 2017
• Study Start: October 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)