Effects of Transvertebral Direct Current Stimulation in Humans
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ClinicalTrials.gov Identifier: NCT04586777 |
Recruitment Status :
Terminated
(Relocation of PI)
First Posted : October 14, 2020
Last Update Posted : January 15, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injuries Paraplegia and Tetraplegia | Device: transvertebral direct current stimulation (tvDCS) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Effects of Transvertebral Direct Current Stimulation in Humans |
Actual Study Start Date : | January 15, 2014 |
Actual Primary Completion Date : | January 8, 2021 |
Actual Study Completion Date : | January 8, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Anodal tvDCS
20 minutes of anodal tvDCS will be applied over the spine at 2.5mA.
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Device: 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. |
Experimental: Cathodal tvDCS
20 minutes of cathodal tvDCS will be applied over the spine at 2.5mA.
|
Device: 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 Comparator: Sham tvDCS
20 minutes of sham tvDCS will be applied over the spine.
|
Device: 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. |
- Change in corticospinal excitability [ Time Frame: Immediately before tvDCS, Immediately after tvDCS ]This will be measured using transcranial magnetic stimulation to evoke responses in muscles of the lower leg.
- Change in spinal cord excitability [ Time Frame: Immediately before tvDCS, Immediately after tvDCS ]Hoffmann's reflex will be used to assess spinal cord excitability. For this text, pulses of electrical stimulation will be applied to the back of the knee and the response will be measured from the calf muscle.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 to 65 years of age
- 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:
- Unstable cardiopulmonary conditions
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586777
United States, Kentucky | |
University of Kentucky at Cardinal Hill Rehabilitation Hospital | |
Lexington, Kentucky, United States, 40504 |
Responsible Party: | Lumy Sawaki, Associate Professor, University of Kentucky |
ClinicalTrials.gov Identifier: | NCT04586777 |
Other Study ID Numbers: |
44067 |
First Posted: | October 14, 2020 Key Record Dates |
Last Update Posted: | January 15, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
neuroplasticity transvertebral direct current stimulation transspinal direct current stimulation |
Spinal Cord Injuries Quadriplegia Paraplegia Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries Paralysis Neurologic Manifestations |