Spinal Cord InjurySCINCT05180227
Transcutaneous Stimulation in Spinal Cord Injury
A study testing DS8R in people with Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Cardiovascular disease has become the leading cause of death in the spinal cord injury population. Increased reliance on the renin-angiotensin-aldosterone system (RAAS) is believed to decrease falls in blood pressure when moving from a laying down position to upright; however, findings in the general population link… 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?
- DS8R
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- above the age of 18 years old
- individuals with traumatic spinal cord injuries at or above T6
- duration of injury if more than 1 year
- non-ambulatory
- American spinal injury association scale A, B or C
- able to provide consent
- non-ventilator
- hypotensive (males: systolic blood pressure less than 110 mmHg and/or diastolic blood pressure less than 70 mmHg; females: systolic blood pressure less than 100 mmHg and/or diastolic blood pressure less than 70 mmHg)
Who cannot join
- acute illness or infection
- documented history of controlled or uncontrolled diabetes
- any other neurological disease other than spinal cord injury
- cardiovascular disease (coronary artery disease, congestive heart failure, peripheral artery disease, stroke)
- present of history of thrombosis in the last 12 months, severe contractures
- pregnant
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: Targeted Transcutaneous Stimulation to Restore Autonomic Cardiovascular Health in Veterans With Spinal Cord Injury
Cardiovascular disease has become the leading cause of death in the spinal cord injury population. Increased reliance on the renin-angiotensin-aldosterone system (RAAS) is believed to decrease falls in blood pressure when moving from a laying down position to upright; however, findings in the general population link the RAAS with remodeling and restructuring of the arterial walls. Therefore, intervention to stabilize and normalize blood pressure should be a priority in individuals with spinal cord injury who have low blood pressure. Advances in stimulation on the skin of the spinal cord offer an approach to restore cardiovascular control and improve blood pressure regulation; however, electrode placement and stimulation parameters needed to increase blood pressure are not well understood. Therefore, the aim of the study is to identify placement of electrodes on the skin, and frequency and amplitude of the stimulation to regulate blood pressure.
Read the detailed description
Although life expectancies have improved in the SCI population, longevity remains below the general population, due to increased incidence of cardiovascular disease, which is the leading cause of mortality in individuals with chronic SCI. Autonomic nervous system dysfunction and blood pressure instability contribute to the increased cardiovascular disease risk in the SCI population; however, because a majority of individuals with SCI remain asymptomatic the diagnosis and treatment of blood pressure instability is not a clinical priority. This is due, in part, to lack of safe and effective interventions, even though mounting evidence strongly supports adverse effects of blood pressure instability on the cerebral circulation, cognitive function, and quality of life. Identifying individualized transcutaneous stimulation parameters that safely and effectively increase and stabilize blood pressure in hypotensive individuals with SCI will provide the foundational evidence to support eventual wide-spread clinical utility throughout the VA healthcare system. 10 participants who are cleared, will go through multiple mapping sessions to find out the most appropriate electrode placement to increase seated blood pressure. The study will take approximately 1 to 13 study visits, of between 3-5 hours, per participant.
- Conditions
- Spinal Cord Injury
- Being tested
- DS8R
- Keywords
- Blood pressure, Orthostatic hypotension, Transcutaneous stimulation, Cardiovascular disease
- Medical subject headings
- Spinal Cord Injuries, Hypotension, Orthostatic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS8RDevice
Also called Transcutaneous Stimulation
transcutaneous stimulation of the spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| Without Stimulation | No intervention | Seated blood pressure without transcutaneous spinal cord stimulation will be assessed. |
| With Stimulation | Active comparator | Seated blood pressure with transcutaneous spinal cord stimulation will be assessed. Receives: Device: DS8R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seated Systolic Blood Pressure
Seated systolic blood pressure response to spinal cord stimulation at T7/T8, T9/10, T11/12, L1/L2) to determine the best cathode electrode placement on the spine that increases systolic blood pressure between 110-130 mmHg.
Measured: From enrollment to the end of the last study visit, approximately 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Jun 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- All participants will complete transcutaneous stimulation mapping sessions to determine the optimal parameters to increase and maintain systolic blood pressure between 110-130 mmHg.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Caitlyn Peters, PhD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180227
- Sponsor's protocol ID
- B3706-M
- Other IDs
- IK1RX003706
- Acronym
- SCI
- Status last verified
- Sep 2025
- First submitted
- 19 Nov 2021
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Peters CG, Harel NY, Weir JP, Wu YK, Murray LM, Chavez J, Fox FE, Cardozo CP, Wecht JM. Transcutaneous Spinal Cord Stimulation to Stabilize Seated Systolic Blood Pressure in Persons With Chronic Spinal Cord Injury: Protocol Development. Neurotrauma Rep. 2023 Dec 19;4(1):838-847. doi: 10.1089/neur.2023.0063. eCollection 2023.
PubMed 38156073
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Transcutaneous Stimulation to Restore Autonomic Cardiovascular Health in Veterans With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05180227
- Acronym / sponsor ID
- SCI / B3706-M
- Conditions
- Spinal Cord Injury
- Keywords
- Blood pressure, Orthostatic hypotension, Transcutaneous stimulation, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular disease has become the leading cause of death in the spinal cord injury population. Increased reliance on the renin-angiotensin-aldosterone system (RAAS) is believed to decrease falls in blood pressure when moving from a laying down position to upright; however, findings in the general population link the RAAS with remodeling and restructuring of the arterial walls. Therefore, intervention to stabilize and normalize blood pressure should be a priority in individuals with spinal cord injury who have low blood pressure. Advances in stimulation on the skin of the spinal cord offer an approach to restore cardiovascular control and improve blood pressure regulation; however, electrode placement and stimulation parameters needed to increase blood pressure are not well understood. Therefore, the aim of the study is to identify placement of electrodes on the skin, and frequency and amplitude of the stimulation to regulate blood pressure.
Detailed description
Although life expectancies have improved in the SCI population, longevity remains below the general population, due to increased incidence of cardiovascular disease, which is the leading cause of mortality in individuals with chronic SCI. Autonomic nervous system dysfunction and blood pressure instability contribute to the increased cardiovascular disease risk in the SCI population; however, because a majority of individuals with SCI remain asymptomatic the diagnosis and treatment of blood pressure instability is not a clinical priority. This is due, in part, to lack of safe and effective interventions, even though mounting evidence strongly supports adverse effects of blood pressure instability on the cerebral circulation, cognitive function, and quality of life. Identifying individualized transcutaneous stimulation parameters that safely and effectively increase and stabilize blood pressure in hypotensive individuals with SCI will provide the foundational evidence to support eventual wide-spread clinical utility throughout the VA healthcare system. 10 participants who are cleared, will go through multiple mapping sessions to find out the most appropriate electrode placement to increase seated blood pressure. The study will take approximately 1 to 13 study visits, of between 3-5 hours, per participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants will complete transcutaneous stimulation mapping sessions to determine the optimal parameters to increase and maintain systolic blood pressure between 110-130 mmHg.
| Arm | Type | Receives |
|---|---|---|
| Without Stimulation | No intervention | –Seated blood pressure without transcutaneous spinal cord stimulation will be assessed. |
| With Stimulation | Active comparator | Device: DS8RSeated blood pressure with transcutaneous spinal cord stimulation will be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- above the age of 18 years old
- individuals with traumatic spinal cord injuries at or above T6
- able to provide consent
- non-ventilator
- hypotensive (males: systolic blood pressure less than 110 mmHg and/or diastolic blood pressure less than 70 mmHg; females: systolic blood pressure less than 100 mmHg and/or diastolic blood pressure less than 70 mmHg)
Key exclusion criteria (6 listed)
- acute illness or infection
- documented history of controlled or uncontrolled diabetes
- any other neurological disease other than spinal cord injury
- cardiovascular disease (coronary artery disease, congestive heart failure, peripheral artery disease, stroke)
- present of history of thrombosis in the last 12 months, severe contractures
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 |
|---|---|---|
| DS8RAlso: Transcutaneous Stimulationtranscutaneous stimulation of the spinal cord. | Device | With Stimulation |
Primary outcome
Seated Systolic Blood Pressure
Time frame: From enrollment to the end of the last study visit, approximately 30 days.
Seated systolic blood pressure response to spinal cord stimulation at T7/T8, T9/10, T11/12, L1/L2) to determine the best cathode electrode placement on the spine that increases systolic blood pressure between 110-130 mmHg.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38156073Peters CG, Harel NY, Weir JP, Wu YK, Murray LM, Chavez J, Fox FE, Cardozo CP, Wecht JM. Transcutaneous Spinal Cord Stimulation to Stabilize Seated Systolic Blood Pressure in Persons With Chronic Spinal Cord Injury: Protocol Development. Neurotrauma Rep. 2023 Dec 19;4(1):838-847. doi: 10.1089/neur.2023.0063. eCollection 2023.
- 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.
Caitlyn Peters, PhD 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 DS8R 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 8 inclusion and 6 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 22 Sep 2025. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Seated Systolic Blood Pressure (time frame: From enrollment to the end of the last study visit, approximately 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05180227, which also lists 1 linked publication.
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 22 Sep 2025.