Spinal Cord InjuryNCT05664646
Autonomic Effects of Stimulation in SCI
A study testing Transcutaneous Spinal Cord Stimulation (TSCS) in people with Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase power output and heart rate recovery during arm cycle ergometry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Transcutaneous Spinal Cord Stimulation (TSCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to 30 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- injury more than 1 year ago, non-ambulatory
- level of lesion C3-T6, AIS A, B, or C
- stable prescription medication regimen for at least 30 days
- must be able to commit to study requirements of 7 visits within a 60-day period
Who cannot join
- extensive history of seizures
- ventilator dependence or patent tracheostomy site
- history of neurologic disorder other than SCI
- history of moderate or severe head trauma
- contraindications to spine stimulation
- significant cardiovascular disease
Show all 9Show fewer
- active psychological disorder
- recent history (within 3 months) of substance abuse
- open skin lesions over spine at levels targeted for stimulation (L1/L2) and pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904
About this study
Official title: Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With SCI
This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase power output and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment.
Read the detailed description
This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise power output and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment. Study 1 (arm cycle ergometry) will consist of 2 visits that will be between 2-3 hours in duration, separated by no less than 3 days, and will consist of putting the electrode at the optimal spot on the spine and completing a submaximal arm ergometry exercise and the other visit will be a sham visit. Study 2 (cool environment) will consist of 2 visits that will be between 3-4 hours in duration, separated by no less than 3 days, and will consist of assessing core temperature when in a cool environment with the stimulator on and off.
- Conditions
- Spinal Cord Injury
- Being tested
- Transcutaneous Spinal Cord Stimulation (TSCS)
- Keywords
- Orthostatic Hypotension, Exercise, Hypotension, Body Core Temperature, Blood Pressure
- Medical subject headings
- Spinal Cord Injuries, Hypotension, Orthostatic, Motor Activity, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Spinal Cord Stimulation (TSCS)Device
Also called TSCS
Non-invasive electrical stimulation of the spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| Without stimulation | Experimental | For study 1, exercise power output and heart rate recovery will be measured after arm ergometry without stimulation. For study 2, body core temperature and thermal comfort will be reported without stimulation. Receives: Device: Transcutaneous Spinal Cord Stimulation (TSCS) |
| With stimulation | Experimental | For study 1, exercise power output and heart rate recovery will be measured after arm ergometry with stimulation. For study 2, body core temperature and thermal comfort will be reported with stimulation. Receives: Device: Transcutaneous Spinal Cord Stimulation (TSCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1. Arm Cycle Ergometry Outcome - Peak Workload
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured in watts.
Measured: through study completion, up to 2 years
Study 1. Arm Cycle Ergometry Outcome - Total Exercise Time
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured in minutes.
Measured: through study completion, up to 2 years
Study 1. Arm Cycle Ergometry Outcome - Recovery Heart Rate
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured at 1 minute, 2 minutes, and 5 minutes.
Measured: through study completion, up to 2 years
Study 2. Thermoregulatory Outcome - Core Temperature
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured in degrees Celsius.
Measured: through study completion, up to 2 years
Study 2. Thermoregulatory Outcome - Thermal Comfort
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured using a Likert scale.
Measured: through study completion, up to 2 years
Study 2. Thermoregulatory Outcome - Thermal Sensation
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured using a Likert scale.
Measured: through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start24 Jul 2023
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Single group
- Model description
- During the study 1 visits, the participants will complete an arm ergometry exercise with the optimal stimulation parameters and without (sham). During study 2 visits, the participants' body core temperature will be measured about being exposed to a cool environment with stimulation and without (sham).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jill Wecht, EdD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664646
- Sponsor's protocol ID
- B4373-P
- Other IDs
- 1I21RX004373-01A1
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Effects of Transcutaneous Spinal Cord Stimulation in Veterans With SCI
- ClinicalTrials.gov ID
- NCT05664646
- Acronym / sponsor ID
- B4373-P
- Conditions
- Spinal Cord Injury
- Keywords
- Orthostatic Hypotension, Exercise, Hypotension, Body Core Temperature, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 27 Dec 2022 (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 aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase power output and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment.
Detailed description
This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise power output and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment. Study 1 (arm cycle ergometry) will consist of 2 visits that will be between 2-3 hours in duration, separated by no less than 3 days, and will consist of putting the electrode at the optimal spot on the spine and completing a submaximal arm ergometry exercise and the other visit will be a sham visit. Study 2 (cool environment) will consist of 2 visits that will be between 3-4 hours in duration, separated by no less than 3 days, and will consist of assessing core temperature when in a cool environment with the stimulator on and off.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- During the study 1 visits, the participants will complete an arm ergometry exercise with the optimal stimulation parameters and without (sham). During study 2 visits, the participants' body core temperature will be measured about being exposed to a cool environment with stimulation and without (sham).
| Arm | Type | Receives |
|---|---|---|
| Without stimulation | Experimental | Device: Transcutaneous Spinal Cord Stimulation (TSCS)For study 1, exercise power output and heart rate recovery will be measured after arm ergometry without stimulation. For study 2, body core temperature and thermal comfort will be reported without stimulation. |
| With stimulation | Experimental | Device: Transcutaneous Spinal Cord Stimulation (TSCS)For study 1, exercise power output and heart rate recovery will be measured after arm ergometry with stimulation. For study 2, body core temperature and thermal comfort will be reported with stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- injury more than 1 year ago, non-ambulatory
- level of lesion C3-T6, AIS A, B, or C
- stable prescription medication regimen for at least 30 days
- must be able to commit to study requirements of 7 visits within a 60-day period
Key exclusion criteria (9 listed)
- extensive history of seizures
- ventilator dependence or patent tracheostomy site
- history of neurologic disorder other than SCI
- history of moderate or severe head trauma
- contraindications to spine stimulation
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 |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation (TSCS)Also: TSCSNon-invasive electrical stimulation of the spinal cord. | Device | With stimulation, Without stimulation |
Primary outcome
Study 1. Arm Cycle Ergometry Outcome - Peak Workload
Time frame: through study completion, up to 2 years
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured in watts.
Study 1. Arm Cycle Ergometry Outcome - Total Exercise Time
Time frame: through study completion, up to 2 years
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured in minutes.
Study 1. Arm Cycle Ergometry Outcome - Recovery Heart Rate
Time frame: through study completion, up to 2 years
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured at 1 minute, 2 minutes, and 5 minutes.
Study 2. Thermoregulatory Outcome - Core Temperature
Time frame: through study completion, up to 2 years
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured in degrees Celsius.
Study 2. Thermoregulatory Outcome - Thermal Comfort
Time frame: through study completion, up to 2 years
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured using a Likert scale.
Study 2. Thermoregulatory Outcome - Thermal Sensation
Time frame: through study completion, up to 2 years
Difference between active transcutaneous spinal cord stimulation (TSCS) and sham TSCS conditions, measured using a Likert scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- 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.
Jill Wecht, EdD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Spinal Cord Stimulation (TSCS) in people with Spinal Cord Injury, run by VA Office of Research and Development 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 4 Sep 2026. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Study 1. Arm Cycle Ergometry Outcome - Peak Workload (time frame: through study completion, up to 2 years). The study lists 6 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 4 Sep 2026.