Effects of Transvertebral Direct Current Stimulation in Humans

Not Applicable

Terminated

• Conditions: Spinal Cord Injuries; Paraplegia and Tetraplegia
• Interventions: Device: transvertebral direct current stimulation (tvDCS)

• Registration Number: NCT04586777
• Lead Sponsor: University of Kentucky

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.

Study Timeline

• Study Start: 2014-01-15
• Study First Submitted: 2020-09-29
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-14
• Status Verified: 2021-01
• Primary Completion: 2021-01-08
• Study Completion: 2021-01-08
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cathodal tvDCS	transvertebral direct current stimulation (tvDCS)	20 minutes of cathodal tvDCS will be applied over the spine at 2.5mA.
Sham tvDCS	transvertebral direct current stimulation (tvDCS)	20 minutes of sham tvDCS will be applied over the spine.
Anodal tvDCS	transvertebral direct current stimulation (tvDCS)	20 minutes of anodal tvDCS will be applied over the spine at 2.5mA.

Primary Outcome Measures

Name	Time	Method
Change in corticospinal excitability	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	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.

Trial Locations

Locations (1)

University of Kentucky at Cardinal Hill Rehabilitation Hospital; 🇺🇸 Lexington, Kentucky, United States