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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
Sponsor:
Information provided by (Responsible Party):
Lumy Sawaki, University of Kentucky

Study Description
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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
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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

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Arms and Interventions
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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
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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
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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
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
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Information from the National Library of Medicine

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


Locations
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United States, Kentucky
University of Kentucky at Cardinal Hill Rehabilitation Hospital
Lexington, Kentucky, United States, 40504
Sponsors and Collaborators
University of Kentucky
More Information
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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

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