Effects of Transvertebral Direct Current Stimulation in Humans

University of Kentucky27 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Spinal Cord Injuries Paraplegia and Tetraplegia

Interventions

transvertebral direct current stimulation (tvDCS)DEVICE

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

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Change in corticospinal excitability

This will be measured using transcranial magnetic stimulation to evoke responses in muscles of the lower leg.

Time frame: Immediately before tvDCS, Immediately after tvDCS

Change in spinal cord excitability

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.

Time frame: Immediately before tvDCS, Immediately after tvDCS

Data from ClinicalTrials.gov

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