Effects of Transvertebral Direct Current Stimulation in Humans
NCT ID: NCT04586777
Last Updated: 2021-01-15
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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TERMINATED
NA
27 participants
INTERVENTIONAL
2014-01-15
2021-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Anodal tvDCS
20 minutes of anodal tvDCS will be applied over the spine at 2.5mA.
transvertebral direct current stimulation (tvDCS)
tvDCS is a painless, non-invasive form of spinal stimulation which delivers safe, low levels of electrical current to the spinal cord through the back. It is believed to be able to influence the excitability of the brain and spinal cord.
Cathodal tvDCS
20 minutes of cathodal tvDCS will be applied over the spine at 2.5mA.
transvertebral direct current stimulation (tvDCS)
tvDCS is a painless, non-invasive form of spinal stimulation which delivers safe, low levels of electrical current to the spinal cord through the back. It is believed to be able to influence the excitability of the brain and spinal cord.
Sham tvDCS
20 minutes of sham tvDCS will be applied over the spine.
transvertebral direct current stimulation (tvDCS)
tvDCS is a painless, non-invasive form of spinal stimulation which delivers safe, low levels of electrical current to the spinal cord through the back. It is believed to be able to influence the excitability of the brain and spinal cord.
Interventions
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transvertebral direct current stimulation (tvDCS)
tvDCS is a painless, non-invasive form of spinal stimulation which delivers safe, low levels of electrical current to the spinal cord through the back. It is believed to be able to influence the excitability of the brain and spinal cord.
Eligibility Criteria
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Inclusion Criteria
* Motor incomplete spinal cord injury classified as B, C, or D by the American Spinal Injury Association Impairment Scale (AIS)
* More than 12 months post-injury
* Lesion at of above thoracic level T8
* Body mass index \<30 (in order to facilitate reliable location of body landmarks guiding stimulation)
* Severe gait deficit
Exclusion Criteria
* History of seizure, head injury with loss of consciousness, severe alcohol or drug abuse, and/or psychiatric illness
* Cognitive deficits severe enough to preclude informed consent
* Positive pregnancy test of being of childbearing age and not using appropriate contraception
* Ferromagnetic material in the brain or in the spine (except for titanium for segmental fixation of the spine)
* Cardiac or neural pacemakers
* Fixed contractures in the lower extremities
* Uncontrolled diabetes
* Severe osteoporosis
* Severe spasticity
* Decubitus ulcers which interfere with harness support or walking
* Severe orthostatic hypotension
18 Years
65 Years
ALL
No
Sponsors
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University of Kentucky
OTHER
Responsible Party
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Lumy Sawaki
Associate Professor
Locations
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University of Kentucky at Cardinal Hill Rehabilitation Hospital
Lexington, Kentucky, United States
Countries
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Other Identifiers
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44067
Identifier Type: -
Identifier Source: org_study_id
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