Effects of Transvertebral Direct Current Stimulation in Humans

Spinal Cord Injuries Clinical Trial

Official title:

Effects of Transvertebral Direct Current Stimulation in Humans

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04586777
• Other study ID #: 44067
• Status: Terminated
• Phase: N/A
• Start date: January 15, 2014
• Est. completion date: January 8, 2021

Study information

• Verified date: January 2021
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: January 8, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Paraplegia
• Paraplegia and Tetraplegia
• Quadriplegia
• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky at Cardinal Hill Rehabilitation Hospital	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in corticospinal excitability	This will be measured using transcranial magnetic stimulation to evoke responses in muscles of the lower leg.	Immediately before tvDCS, Immediately after tvDCS
Primary	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.	Immediately before tvDCS, Immediately after tvDCS