Spinal Cord InjuriesSCINCT05725499
The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)
A study testing Biostim-5 transcutaneous spinal stimulator and Tilt-table orthostatic stress testing in people with Spinal Cord Injuries and Hypotension, run by Kessler Foundation at 1 site in United States.
Trial summary
This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright… 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?
- Biostim-5 transcutaneous spinal stimulator and Tilt-table orthostatic stress testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Aug 2026
- 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
- Spinal cord injury for greater than or equal to 6 months
- Injury level ≥ T6 (thoracic level)
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D
- Exhibits at least one of the following hypotensive symptoms:
- Baseline hypotension - resting supine or seated systolic blood pressure(SBP) < 90mmHg;
- SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position;
- Symptoms of orthostasis with a drop of SBP (<90mmHg) from supine to sitting
Who cannot join
- Current illness (infection, a pressure injury that might interfere with the intervention, a recent diagnosis of DVT/PE, etc.)
- 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
- Insufficient mental capacity to understand and independently provide consent
Show all 9Show fewer
- Pregnancy
- Cancer
- Deemed unsuitable by 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, 1 recruiting
- Recruiting
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: Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Chronic Spinal Cord Injury
This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position).
The main questions it aims to answer are:
Read more
- What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)?
- Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability?
Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.
Read the detailed description
Cardiovascular (CV) control in persons with a high level (thoracic level T6 or above) spinal cord injury (SCI) is often impaired, resulting in short and long-term health complications and a decline in quality of life. Orthostatic hypotension (OH), a significant decrease in blood pressure (BP) when moving from lying flat (supine) to an upright position, appears early after injury and is frequently accompanied by dizziness, weakness, fatigue, and even syncope. In the long term, while symptoms are typically diminished, it still clinically occurs in 50% of individuals with a cervical injury. The physical, social, and emotional consequences of OH pose a major issue. Moreover, BP instability is associated with a decline in CV health and somewhat accounts for the 3 to 4-fold increased risk for stroke and heart disease in this clinical population.
In recent years, epidural spinal cord stimulation has been explored with promising results as a potential treatment for CV dysfunction. Spinal cord transcutaneous stimulation (scTS) represents an alternate approach, with the potential to benefit more people with fewer risks. Only one study thus far successfully applied scTS to restore CV function and resolve orthostatic symptoms following SCI, with stimulation applied at one thoracic location.
The objective of this study is to investigate the effect of scTS on BP in individuals with chronic SCI who experience OH. Stimulation sites and parameters that consistently increase and stabilize systolic BP within the range of 110-120 mmHg, during an orthostatic provocation (a 70° tilt-test), will be sought. The investigators will also evaluate whether there is any change in the BP response following repeated stimulation sessions. This project will provide the foundational evidence to use scTS to improve autonomic function in various SCI populations and help overcome barriers to engagement in activity and participation imposed by autonomic dysfunction.
- Conditions
- Spinal Cord Injuries, Hypotension, Orthostatic Hypotension, Spinal Cord Diseases, Cardiovascular Diseases, Trauma, Nervous System
- Being tested
- Biostim-5 transcutaneous spinal stimulator, Tilt-table orthostatic stress testing
- Keywords
- Transcutaneous Spinal Cord Stimulation, Spinal Stimulation, 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.
Biostim-5 transcutaneous spinal stimulatorDevice
Transcutaneous stimulation of the spinal cord. Mapping will be performed to determine sites for optimal modulation of blood pressure. During each mapping day, with participants in a supine or seated position, electrodes will be placed on the midline of one of the following spinous processes: C5/6, T7/8, T11/12, L1/2 and S1/2. Stimulation intensity will start at 5 mA and gradually increased in 5 mA increments up to 100 mA. The frequency will be 2 or 30 Hz. Profiles will be established to guide selection of optimal site locations for blood pressure modulation. The profile chosen will be used during training and testing.
During testing, stimulation will be applied using the selected profile in order to normalize SBP to the range of 110-120 mmHg and stabilize it within this range during a 30-min tilt test.
On each session during the 2-week training-period, stimulation will be applied for 30 minutes using the selected profile, while the participant remains in a seated position.
Tilt-table orthostatic stress testingDiagnostic test
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 some of the sessions, the tilt test will be accompanied by spinal stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Participants with a chronic SCI (≥ 6 months after injury) | Experimental | Participants will complete three days of baseline assessments (including a baseline orthostatic test and a day of neurophysiological mapping), five days of stimulation mapping to locate the optimal spinal sites for a blood pressure response, a day of testing with stimulation applied during an orthostatic provocation and a two-week (total of six days) training period with repeated exposure to stimulation, followed by two days of additional orthostatic tests (with and without stimulation) Receives: Device: Biostim-5 transcutaneous spinal stimulator; Diagnostic Test: Tilt-table orthostatic stress testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal stimulation sites
Identify scTS spinal segments that restore systolic BP within the normotensive range (110-120 mmHg).
Measured: Through Mapping and testing sessions, average of 3 weeks
Optimal stimulation frequency
Identify scTS frequency that restores systolic BP within the normotensive range (110-120 mmHg).
Measured: Through Mapping and testing sessions, average of 3 weeks
Systolic blood pressure - efficacy of stimulation
Evaluate changes in blood pressure during an orthostatic test (comparing measurements obtained during stimulation to those obtained without).
The ability of scTS to normalize SBP (to the range of 110-120) and to stabilize it over the course of a 30-min tilt test will be assessed.
Measured: Throughout the experiment, average of 6 weeks
Systolic blood pressure - effect of training
Explore the blood pressure response to orthostatic stress with and without stimulation, following six days of repetitive 30-min customized scTS sessions
Measured: Post training, average of 2 weeks
Orthostatic symptoms questionnaire
A questionnaire ranking the severity of orthostatic symptoms (dizziness, nausea), with a scale of 1-10 (10 being the most severe).
Measured: Throughout the experiment, average of 6 weeks
Secondary outcomes (5)
EMG of leg muscles - muscle activation (analysis of mean and peak amplitudes)
Analysis of leg-muscle EMG to identify configurations that modulate BP without eliciting motor activity, to ensure that BP response was not due to lower limb muscle contraction.
Measured: Through Mapping and testing sessions, average of 3 weeks
Spinal Cord Injury-Quality of Life (SCI-QOL) questionnaires
Accessible through computer adaptive testing and addresses the following domains: emotional health, physical-medical health, social participation, and physical function
Measured: Before the first session and after the last session, average of 6 weeks
Global response assessment (GRA)
GRA will be used to evaluate patients' perceptions of treatment effectiveness
Measured: post training, average of 6 weeks
Additional hemodynamic measure - diastolic blood pressure
Hemodynamic measures will be collected throughout the trial
Measured: throughout the trial, average of 6 weeks
Additional hemodynamic measure - heart rate
Hemodynamic measures will be collected throughout the trial
Measured: throughout the trial, average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Feb 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Einat Haber, Kessler Foundation
- Investigators
- Gail F Forrest, Phd, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725499
- Sponsor's protocol ID
- R.1197.22
- Other IDs
- PC8-23
- Acronym
- SCI
- Status last verified
- Aug 2025
- First submitted
- 25 Jan 2023
- Last updated
- 2 Sep 2025
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05725499
- Acronym / sponsor ID
- SCI / R.1197.22
- Conditions
- Spinal Cord Injuries, Hypotension, Orthostatic Hypotension, Spinal Cord Diseases, Cardiovascular Diseases, Trauma, Nervous System
- Keywords
- Transcutaneous Spinal Cord Stimulation, Spinal Stimulation, Orthostatic Hypotension, Blood Pressure, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 Feb 2023 (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 project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position).
The main questions it aims to answer are:
- What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)?
- Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability?
Participants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.
Detailed description
Cardiovascular (CV) control in persons with a high level (thoracic level T6 or above) spinal cord injury (SCI) is often impaired, resulting in short and long-term health complications and a decline in quality of life. Orthostatic hypotension (OH), a significant decrease in blood pressure (BP) when moving from lying flat (supine) to an upright position, appears early after injury and is frequently accompanied by dizziness, weakness, fatigue, and even syncope. In the long term, while symptoms are typically diminished, it still clinically occurs in 50% of individuals with a cervical injury. The physical, social, and emotional consequences of OH pose a major issue. Moreover, BP instability is associated with a decline in CV health and somewhat accounts for the 3 to 4-fold increased risk for stroke and heart disease in this clinical population.
In recent years, epidural spinal cord stimulation has been explored with promising results as a potential treatment for CV dysfunction. Spinal cord transcutaneous stimulation (scTS) represents an alternate approach, with the potential to benefit more people with fewer risks. Only one study thus far successfully applied scTS to restore CV function and resolve orthostatic symptoms following SCI, with stimulation applied at one thoracic location.
The objective of this study is to investigate the effect of scTS on BP in individuals with chronic SCI who experience OH. Stimulation sites and parameters that consistently increase and stabilize systolic BP within the range of 110-120 mmHg, during an orthostatic provocation (a 70° tilt-test), will be sought. The investigators will also evaluate whether there is any change in the BP response following repeated stimulation sessions. This project will provide the foundational evidence to use scTS to improve autonomic function in various SCI populations and help overcome barriers to engagement in activity and participation imposed by autonomic dysfunction.
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 a chronic SCI (≥ 6 months after injury) | Experimental | Device: Biostim-5 transcutaneous spinal stimulator, Diagnostic Test: Tilt-table orthostatic stress testingParticipants will complete three days of baseline assessments (including a baseline orthostatic test and a day of neurophysiological mapping), five days of stimulation mapping to locate the optimal spinal sites for a blood pressure response, a day of testing with stimulation applied during an orthostatic provocation and a two-week (total of six days) training period with repeated exposure to stimulation, followed by two days of additional orthostatic tests (with and without stimulation) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Spinal cord injury for greater than or equal to 6 months
- Injury level ≥ T6 (thoracic level)
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D
- Exhibits at least one of the following hypotensive symptoms:
Key exclusion criteria (9 listed)
- Current illness (infection, a pressure injury that might interfere with the intervention, a recent diagnosis of DVT/PE, etc.)
- 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 |
|---|---|---|
| Biostim-5 transcutaneous spinal stimulatorTranscutaneous stimulation of the spinal cord. Mapping will be performed to determine sites for optimal modulation of blood pressure. During each mapping day, with participants in a supine or seated position, electrodes will be placed on the midline of one of the following spinous processes: C5/6, T7/8, T11/12, L1/2 and S1/2. Stimulation intensity will start at 5 mA and gradually increased in 5 mA increments up to 100 mA. The frequency will be 2 or 30 Hz. Profiles will be established to guide selection of optimal site locations for blood pressure modulation. The profile chosen will be used during training and testing. During testing, stimulation will be applied using the selected profile in order to normalize SBP to the range of 110-120 mmHg and stabilize it within this range during a 30-min tilt test. On each session during the 2-week training-period, stimulation will be applied for 30 minutes using the selected profile, while the participant remains in a seated position. | Device | Participants with a chronic SCI (≥ 6 months after injury) |
| Tilt-table orthostatic stress testingWhile 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 some of the sessions, the tilt test will be accompanied by spinal stimulation. | Diagnostic test | Participants with a chronic SCI (≥ 6 months after injury) |
Primary outcome
Optimal stimulation sites
Time frame: Through Mapping and testing sessions, average of 3 weeks
Identify scTS spinal segments that restore systolic BP within the normotensive range (110-120 mmHg).
Optimal stimulation frequency
Time frame: Through Mapping and testing sessions, average of 3 weeks
Identify scTS frequency that restores systolic BP within the normotensive range (110-120 mmHg).
Systolic blood pressure - efficacy of stimulation
Time frame: Throughout the experiment, average of 6 weeks
Evaluate changes in blood pressure during an orthostatic test (comparing measurements obtained during stimulation to those obtained without). The ability of scTS to normalize SBP (to the range of 110-120) and to stabilize it over the course of a 30-min tilt test will be assessed.
Systolic blood pressure - effect of training
Time frame: Post training, average of 2 weeks
Explore the blood pressure response to orthostatic stress with and without stimulation, following six days of repetitive 30-min customized scTS sessions
Orthostatic symptoms questionnaire
Time frame: Throughout the experiment, average of 6 weeks
A questionnaire ranking the severity of orthostatic symptoms (dizziness, nausea), with a scale of 1-10 (10 being the most severe).
5 secondary outcomes
EMG of leg muscles - muscle activation (analysis of mean and peak amplitudes)
Time frame: Through Mapping and testing sessions, average of 3 weeks
Spinal Cord Injury-Quality of Life (SCI-QOL) questionnaires
Time frame: Before the first session and after the last session, average of 6 weeks
Global response assessment (GRA)
Time frame: post training, average of 6 weeks
Additional hemodynamic measure - diastolic blood pressure
Time frame: throughout the trial, average of 6 weeks
Additional hemodynamic measure - heart rate
Time frame: throughout the trial, average of 6 weeks
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 2 Sep 2025.
- 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 Biostim-5 transcutaneous spinal stimulator and Tilt-table orthostatic stress testing 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: looking for participants now, as of the sponsor's last update on 2 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?
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 ((973)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?
Optimal stimulation sites (time frame: Through Mapping and testing sessions, average of 3 weeks). The study lists 5 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 2 Sep 2025.