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Effects of Transvertebral Direct Current Stimulation in Humans

Effects of Transvertebral Direct Current Stimulation in Humans

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04586777
Enrollment
27
Registered
2020-10-14
Start date
2014-01-15
Completion date
2021-01-08
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paraplegia and Tetraplegia, Spinal Cord Injuries

Keywords

neuroplasticity, transvertebral direct current stimulation, transspinal direct current stimulation

Brief summary

This study will evaluate the effects of non-invasive stimulation of the spinal cord in people with spinal cord injury.

Detailed description

This study will use a non-invasive form of spinal stimulation, called transvertebral direct current stimulation, or tvDCS. It currently is not clear what effects this type of stimulation has on the excitability of the brain and spinal cord in people with spinal cord injury. In this study, subjects will participate in 3 sessions, with at least 1 week in between sessions, during which they will get a different condition of tvDCS. We will test the excitability of the brain and spinal cord before and after tvDCS in each session.

Interventions

DEVICEtransvertebral 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.

Sponsors

University of Kentucky
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in corticospinal excitabilityImmediately before tvDCS, Immediately after tvDCSThis will be measured using transcranial magnetic stimulation to evoke responses in muscles of the lower leg.
Change in spinal cord excitabilityImmediately before tvDCS, Immediately after tvDCSHoffmann'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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026