Spinal Cord InjuriesNCT04586777
Effects of Transvertebral Direct Current Stimulation in Humans
A study testing transvertebral direct current stimulation (tvDCS) in people with Spinal Cord Injuries and Paraplegia and Tetraplegia, run by University of Kentucky at 1 site in United States.
Trial summary
This study will evaluate the effects of non-invasive stimulation of the spinal cord in people with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Paraplegia and Tetraplegia
- What is being tested?
- transvertebral direct current stimulation (tvDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2014to 8 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- Fixed contractures in the lower extremities
- Uncontrolled diabetes
- Severe osteoporosis
- Severe spasticity
- Decubitus ulcers which interfere with harness support or walking
- Severe orthostatic hypotension
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky at Cardinal Hill Rehabilitation Hospital
Lexington, Kentucky, 40504
About this study
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.
- Conditions
- Spinal Cord Injuries, Paraplegia and Tetraplegia
- Being tested
- transvertebral direct current stimulation (tvDCS)
- Keywords
- neuroplasticity, transvertebral direct current stimulation, transspinal direct current stimulation
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvertebral direct current stimulation (tvDCS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tvDCS | Experimental | 20 minutes of anodal tvDCS will be applied over the spine at 2.5mA. Receives: Device: transvertebral direct current stimulation (tvDCS) |
| Cathodal tvDCS | Experimental | 20 minutes of cathodal tvDCS will be applied over the spine at 2.5mA. Receives: Device: transvertebral direct current stimulation (tvDCS) |
| Sham tvDCS | Sham comparator | 20 minutes of sham tvDCS will be applied over the spine. Receives: Device: transvertebral direct current stimulation (tvDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corticospinal excitability
This will be measured using transcranial magnetic stimulation to evoke responses in muscles of the lower leg.
Measured: Immediately before tvDCS, Immediately after tvDCS
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.
Measured: Immediately before tvDCS, Immediately after tvDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start15 Jan 2014
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Why it stopped: Relocation of PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lumy Sawaki, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586777
- Sponsor's protocol ID
- 44067
- Status last verified
- Jan 2021
- First submitted
- 29 Sep 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transvertebral Direct Current Stimulation in Humans
- ClinicalTrials.gov ID
- NCT04586777
- Acronym / sponsor ID
- 44067
- Conditions
- Spinal Cord Injuries, Paraplegia and Tetraplegia
- Keywords
- neuroplasticity, transvertebral direct current stimulation, transspinal direct current stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Relocation of PI
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 15 Jan 2014 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tvDCS | Experimental | Device: transvertebral direct current stimulation (tvDCS)20 minutes of anodal tvDCS will be applied over the spine at 2.5mA. |
| Cathodal tvDCS | Experimental | Device: transvertebral direct current stimulation (tvDCS)20 minutes of cathodal tvDCS will be applied over the spine at 2.5mA. |
| Sham tvDCS | Sham comparator | Device: transvertebral direct current stimulation (tvDCS)20 minutes of sham tvDCS will be applied over the spine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Anodal tvDCS, Cathodal tvDCS, Sham tvDCS |
Primary outcome
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.
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.
Results and safety
The study was stopped early (reason given: Relocation of PI). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transvertebral direct current stimulation (tvDCS) in people with Spinal Cord Injuries and Paraplegia and Tetraplegia, run by University of Kentucky at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Relocation of PI). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in corticospinal excitability (time frame: Immediately before tvDCS, Immediately after tvDCS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.