Spinal Cord Injuries(SCI)NCT07674511
Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury
A study testing Tilt test with stimulation (real-time effects): Intervention 1 and 20 sessions of stimulation (Intervention 2) in people with Spinal Cord Injuries and Hypotension, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury. The main questions this study attempts to solve: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Hypotension, Orthostatic Hypotension
- What is being tested?
- Tilt test with stimulation (real-time effects): Intervention 1 and 20 sessions of stimulation (Intervention 2)
- 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
- Sep 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a SCI ≥ 1 year after injury
- Injury level ≥ T6 (thoracic level)
- AIS grade A-C
- Cardiovascular dysfunction characterized by one or more of the following:
- Persistent hypotension (SBP < 90mmHg)
- Orthostatic hypotension (OH, a drop of 20/10 mmHg in SBP/DBP within 5 minutes of standing/upright positioning).
- Additionally, experiencing orthostatic symptoms in daily life and/or requiring medication to manage OH.
Who cannot join
- Current illness (e.g., infection, a pressure injury that might interfere with the intervention)
- Ventilator-dependent
- History of implanted brain/spine/nerve stimulators
- Cardiac pacemaker/defibrillator or intra-cardiac lines
- Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction
- History of seizures
Show all 9Show fewer
- pregnancy
- Insufficient mental capacity to understand and independently provide consent
- Deemed unsuitable by the study physician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Einat Engel-Haber, MD contact
United States1 site
Kessler Foundation
West Orange, New Jersey, 07052
LeighAnn Martinez, BA, (973)324-3557, lmartinez@kesslerfoundation.org
Einat Engel-Haber, MD, ehaber@kesslerfoundation.org
About this study
Official title: Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury: Short and Long-Term Effects
The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury.
The main questions this study attempts to solve:
- What are the immediate effects of spinal cord transcutaneous stimulation on BP?
- Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?
Read the detailed description
We want to find out if this stimulation can help both right away (during a session) and over time (after several sessions). Specifically, this study will look at whether spinal stimulation can treat orthostatic hypotension, which is a drop in blood pressure that happens when the patient moves from lying down to sitting or standing up. To take part, one must have had a spinal cord injury for more than one year.
- Conditions
- Spinal Cord Injuries, Hypotension, Orthostatic Hypotension, Spinal Cord Diseases, Cardiovascular Diseases, Trauma, Nervous System
- Being tested
- Tilt test with stimulation (real-time effects): Intervention 1, 20 sessions of stimulation (Intervention 2)
- Keywords
- transcutaneous spinal cord stimulation, spinal stimulations, orthostatic hypotension, blood pressure, neuromodulation
- Medical subject headings
- Spinal Cord Injuries, Hypotension, Hypotension, Orthostatic, Spinal Cord Diseases, Cardiovascular Diseases, Trauma, Nervous System, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tilt test with stimulation (real-time effects): Intervention 1Device
While lying supine, participants will be strapped to a Hi-Low tilt-table bed. The bed will gradually be tilted to a 70 degrees tilt, during which time continuous hemodynamic measures will be recorded. This position will be maintained for 30 minutes. During tilt, transcutaneous stimulation will be applied, using the configuration that was chosen based on the mapping sessions.
20 sessions of stimulation (Intervention 2)Device
Participants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs
| Study group | Role | What they receive |
|---|---|---|
| participants with chronic SCIs. | Experimental | Participation in this study will take about 5 to 6 months and will include approximately 30 to 40 separate lab visits. Most visits will last about 2 hours, though some of the early visits may take longer.
The study consists of:
1. Baseline assessments, including a tilt test and various cardiovascular assessments
2. Mapping stimulation sessions - several days when different stimulation parameters and locations are tested in order to obtain the configurations for the most suitable blood pressure response.
3. Repeat tilt test, with stimulation (intervention 1), with continuous blood pressure monitoring
4. 20 stimulation sessions, each 30-min long, with participants in their wheelchairs (intervention 2)
5. Repeat baseline assessments Receives: Device: Tilt test with stimulation (real-time effects): Intervention 1; Device: 20 sessions of stimulation (Intervention 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Evaluate changes in blood pressure during an orthostatic tilt test comparing stimulation to no stimulation.
Measured: 1 month
Systolic blood pressure
changes in blood pressure drop with tilt (no stimulation) from baseline testing to tilt test (no stimulation) after 20 sessions of stimulation
Measured: Through study completion, an average of 5 months
Secondary outcomes (6)
duration in tilt test
how long the participant was able to stay in an orthostatic provocation (70 degrees tilt in tilt table)
Measured: Through study completion, an average of 5 months
Orthostatic symptoms questionnaire
A designated questionnaire evaluates symptoms such as headaches, dizziness, blurred vision, nausea, weakness, confusion, fatigue, ringing in the ears, and feeling of passing out. Recorded every 5 minutes (or sooner if symptoms worsen). Participants rate each symptom on a scale of 0 to 10, with 10 indicating the highest severity.
Measured: Through study completion, an average of 5 months
24-hour ABPM OH events - taken at home
Parameters are recorded automatically every 15 min during the day and every 60 min at night. Participants will be asked to take notes regarding BP-related symptoms, activities and their time-points. Conducted before, halfway through, and after the intervention
Measured: Through study completion, an average of 5 months
Autonomic Dysfunction Following Spinal Cord Injury questionnaire scores
24-item self-reported tool designed for clinical practice and research to assess symptoms of BP instability. It evaluates the frequency and severity of symptoms during high and low BP events
Measured: Through study completion, an average of 5 months
Spinal cord injury - quality of life scores
A questionnaire was developed to address the shortage of psychometrically sound and relevant patient-reported outcome measures for clinical care and research in SCI rehabilitation
Measured: Through study completion, an average of 5 months
Canadian Occupational Performance Measure scores
A semi-structure interview where the individual identifies and measures their areas of difficulty, scoring their performance on the tasks and their satisfaction with their ability
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
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.
- More trials run by Kessler FoundationThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Montclair State University
- Responsible party
- Principal investigator, Einat Haber, Kessler Foundation
- Investigators
- Gail F Forrest, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674511
- Sponsor's protocol ID
- R-1323-26
- Other IDs
- 1R03HD120505-01
- Acronym
- (SCI)
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury: Short and Long-Term Effects
- ClinicalTrials.gov ID
- NCT07674511
- Acronym / sponsor ID
- (SCI) / R-1323-26
- Conditions
- Spinal Cord Injuries, Hypotension, Orthostatic Hypotension, Spinal Cord Diseases, Cardiovascular Diseases, Trauma, Nervous System
- Keywords
- transcutaneous spinal cord stimulation, spinal stimulations, orthostatic hypotension, blood pressure, neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Montclair State University
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Jun 2026 (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.
The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury.
The main questions this study attempts to solve:
- What are the immediate effects of spinal cord transcutaneous stimulation on BP?
- Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?
Detailed description
We want to find out if this stimulation can help both right away (during a session) and over time (after several sessions). Specifically, this study will look at whether spinal stimulation can treat orthostatic hypotension, which is a drop in blood pressure that happens when the patient moves from lying down to sitting or standing up. To take part, one must have had a spinal cord injury for more than one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants with chronic SCIs. | Experimental | Device: Tilt test with stimulation (real-time effects): Intervention 1, Device: 20 sessions of stimulation (Intervention 2)Participation in this study will take about 5 to 6 months and will include approximately 30 to 40 separate lab visits. Most visits will last about 2 hours, though some of the early visits may take longer. The study consists of: 1. Baseline assessments, including a tilt test and various cardiovascular assessments 2. Mapping stimulation sessions - several days when different stimulation parameters and locations are tested in order to obtain the configurations for the most suitable blood pressure response. 3. Repeat tilt test, with stimulation (intervention 1), with continuous blood pressure monitoring 4. 20 stimulation sessions, each 30-min long, with participants in their wheelchairs (intervention 2) 5. Repeat baseline assessments |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals with a SCI ≥ 1 year after injury
- Injury level ≥ T6 (thoracic level)
- AIS grade A-C
- Cardiovascular dysfunction characterized by one or more of the following:
- Additionally, experiencing orthostatic symptoms in daily life and/or requiring medication to manage OH.
Key exclusion criteria (9 listed)
- Current illness (e.g., infection, a pressure injury that might interfere with the intervention)
- Ventilator-dependent
- History of implanted brain/spine/nerve stimulators
- Cardiac pacemaker/defibrillator or intra-cardiac lines
- Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction
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 |
|---|---|---|
| Tilt test with stimulation (real-time effects): Intervention 1While lying supine, participants will be strapped to a Hi-Low tilt-table bed. The bed will gradually be tilted to a 70 degrees tilt, during which time continuous hemodynamic measures will be recorded. This position will be maintained for 30 minutes. During tilt, transcutaneous stimulation will be applied, using the configuration that was chosen based on the mapping sessions. | Device | participants with chronic SCIs. |
| 20 sessions of stimulation (Intervention 2)Participants will undergo 20 separate 30-minute sessions of transcutaneous spinal cord stimulation while seated in their wheelchairs | Device | participants with chronic SCIs. |
Primary outcome
Systolic blood pressure
Time frame: 1 month
Evaluate changes in blood pressure during an orthostatic tilt test comparing stimulation to no stimulation.
Systolic blood pressure
Time frame: Through study completion, an average of 5 months
changes in blood pressure drop with tilt (no stimulation) from baseline testing to tilt test (no stimulation) after 20 sessions of stimulation
6 secondary outcomes
duration in tilt test
Time frame: Through study completion, an average of 5 months
Orthostatic symptoms questionnaire
Time frame: Through study completion, an average of 5 months
24-hour ABPM OH events - taken at home
Time frame: Through study completion, an average of 5 months
Autonomic Dysfunction Following Spinal Cord Injury questionnaire scores
Time frame: Through study completion, an average of 5 months
Spinal cord injury - quality of life scores
Time frame: Through study completion, an average of 5 months
Canadian Occupational Performance Measure scores
Time frame: Through study completion, an average of 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 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.
Einat Engel-Haber, MD contact
Gail F Forrest, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tilt test with stimulation (real-time effects): Intervention 1 and 20 sessions of stimulation (Intervention 2) in people with Spinal Cord Injuries and Hypotension, run by Kessler Foundation 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 7 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: opening soon, as of the sponsor's last update on 29 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LeighAnn Martinez, BA (972-324-3557, lmartinez@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 1 month). 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 29 Jun 2026.