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Effects of Transvertebral Direct Current Stimulation in Humans

Primary Purpose

Spinal Cord Injuries, Paraplegia and Tetraplegia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transvertebral direct current stimulation (tvDCS)
Sponsored by
University of Kentucky
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring neuroplasticity, transvertebral direct current stimulation, transspinal direct current stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky at Cardinal Hill Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Anodal tvDCS

Cathodal tvDCS

Sham tvDCS

Arm Description

20 minutes of anodal tvDCS will be applied over the spine at 2.5mA.

20 minutes of cathodal tvDCS will be applied over the spine at 2.5mA.

20 minutes of sham tvDCS will be applied over the spine.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 29, 2020
Last Updated
January 13, 2021
Sponsor
University of Kentucky
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1. Study Identification

Unique Protocol Identification Number
NCT04586777
Brief Title
Effects of Transvertebral Direct Current Stimulation in Humans
Official Title
Effects of Transvertebral Direct Current Stimulation in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Relocation of PI
Study Start Date
January 15, 2014 (Actual)
Primary Completion Date
January 8, 2021 (Actual)
Study Completion Date
January 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Paraplegia and Tetraplegia
Keywords
neuroplasticity, transvertebral direct current stimulation, transspinal direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal tvDCS
Arm Type
Experimental
Arm Description
20 minutes of anodal tvDCS will be applied over the spine at 2.5mA.
Arm Title
Cathodal tvDCS
Arm Type
Experimental
Arm Description
20 minutes of cathodal tvDCS will be applied over the spine at 2.5mA.
Arm Title
Sham tvDCS
Arm Type
Sham Comparator
Arm Description
20 minutes of sham tvDCS will be applied over the spine.
Intervention Type
Device
Intervention Name(s)
transvertebral direct current stimulation (tvDCS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in corticospinal excitability
Description
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
Title
Change in spinal cord excitability
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Kentucky at Cardinal Hill Rehabilitation Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Transvertebral Direct Current Stimulation in Humans

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