CClinicalTrials.gg
TerminatedNCT04586777Updated Jan 15, 2021

Effects of Transvertebral Direct Current Stimulation in Humans

An interventional study of transvertebral direct current stimulation (tvDCS) in Spinal Cord Injuries and Paraplegia and Tetraplegia, sponsored by University of Kentucky. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-01-15.

Sponsored by University of Kentucky · Not applicable, Interventional, and Treatment

Why this study was terminated
Relocation of PI

From the registry’s dates

  • Registered 6 years 8 months after the study started (first participant enrolled Jan 2014, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Spinal Cord Injuries
  • Paraplegia and Tetraplegia

Keywords

  • neuroplasticity
  • transvertebral direct current stimulation
  • transspinal direct current stimulation
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 27 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

University of Kentucky is the lead sponsor of 68 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Anodal tvDCS

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

    Device: transvertebral direct current stimulation (tvDCS)

  • Experimental
    Cathodal tvDCS

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

    Device: transvertebral direct current stimulation (tvDCS)

  • Sham comparator
    Sham tvDCS

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

    Device: transvertebral direct current stimulation (tvDCS)

Interventions

  • Devicetransvertebral 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • University of Kentucky at Cardinal Hill Rehabilitation Hospital
    Lexington, Kentucky 40504, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04586777
Lead sponsor
University of Kentucky
Responsible party
Lumy Sawaki (Associate Professor, University of Kentucky) — Principal investigator
First posted
Oct 14, 2020
Start date
Jan 15, 2014
Primary completion
Jan 8, 2021
Completion
Jan 8, 2021
Last update
Jan 15, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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