The Biophysical Impact of Transcutaneous Spinal Cord Stimulation Within a Single Session
NCT ID: NCT03046875
Last Updated: 2018-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-10-31
2017-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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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.
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.
Sham
Subjects will participate in a single session of isokinetic strength testing of knee extension with sham stimulation.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
OTHER
Responsible Party
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Rebecca Martin, OTR/L, OTD
Manager Clinical Education and Training, International Center for Spinal Cord Injury Assistant Professor, Johns Hopkins School of Medicine, Dept. of Physical Medicine and Rehabilitation
Principal Investigators
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Rebecca Martin, OTR/L, OTD, CPAM
Role: PRINCIPAL_INVESTIGATOR
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Locations
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Rebecca Martin, OTR/L, OTD, CPAM
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00103592
Identifier Type: -
Identifier Source: org_study_id
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