Effects of Transvertebral Direct Current Stimulation in Humans

• ClinicalTrials.gov Identifier: NCT04586777
• Recruitment Status: Terminated
• First Posted: October 14, 2020
• Last Update Posted: January 15, 2021
• Sponsor: University of Kentucky
• Information provided by (Responsible Party): Lumy Sawaki, University of Kentucky

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries; Paraplegia and Tetraplegia	Device: transvertebral direct current stimulation (tvDCS)	Not Applicable

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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Anodal tvDCS; 20 minutes of anodal 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.
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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Kentucky

University of Kentucky at Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, United States, 40504

Sponsors and Collaborators

University of Kentucky

More Information

• Responsible Party: Lumy Sawaki, Associate Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT04586777
• Other Study ID Numbers: 44067
• First Posted: October 14, 2020
• 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

Keywords provided by Lumy Sawaki, University of Kentucky:

neuroplasticity; transvertebral direct current stimulation; transspinal direct current stimulation

Additional relevant MeSH terms:

Spinal Cord Injuries; Quadriplegia; Paraplegia; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations