Spinal Cord InjuriesSCINCT05731986
Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)
A study testing Orthostatic challenge, Biostim-5 transcutaneous spinal stimulation - Mapping and Biostim-5 transcutaneous spinal stimulation - "Optimal" testing in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Kessler Foundation at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases, Trauma, Nervous System
- What is being tested?
- Orthostatic challenge, Biostim-5 transcutaneous spinal stimulation - Mapping and Biostim-5 transcutaneous spinal stimulation - "Optimal" testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 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
- 7-30 days after injury
- Injury level ≥T2 (thoracic level)
- American Spinal Injury Association Impairment Scale (AIS) A-C
- Exhibits at least one of the following hypotensive symptoms:
- Baseline hypotension - resting supine or seated 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 (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the intervention, etc.) or infection
- 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
- Initiated on new cardiac medications within the past 5 days
Show all 10Show fewer
- Insufficient mental capacity to understand and independently provide consent
- 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 Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study
The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period.
The main questions it aims to answer are:
Read more
- Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared.
- What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg?
Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.
Read the detailed description
Blood pressure (BP) control in persons with a spinal cord injury (SCI) is often impaired, resulting in short and long-term health complications and a decline in quality of life. Cardiovascular (CV) dysfunction develops early after SCI and often continues a lifetime. Orthostatic hypotension (OH), a 20/10 mmHg decrease in systolic/diastolic BP when moving from a supine to an upright position, is especially prevalent in the early phase, and frequently accompanied by symptoms of dizziness, weakness, fatigue, and syncope. Affecting up to 75% of therapy treatments during inpatient rehabilitation, OH significantly interferes with participation during the critical rehab time-period, especially as length of stay in rehabilitation has substantially shortened in the past decades.
The compelling rationale for early identification and treatment of OH is met by several pharmacological and non-pharmacological interventions, however, the majority have limited effect, and increase the risk of adverse drug effects due to polypharmacy. In recent years, epidural and transcutaneous spinal cord stimulation has been explored with promising results as a potential treatment to CV dysfunction in SCI. To date, only individuals with a chronic SCI (>1 year) were included in these studies.
The objective of this study is to investigate the effect of spinal cord transcutaneous stimulation (scTS) on BP in individuals with an acute/sub-acute SCI (7-30 days after injury), during their inpatient rehabilitation. Optimal stimulation sites and parameters that increase and stabilize systolic BP (SBP) within the normotensive range (110-120 mmHg) during an orthostatic challenge will be sought. In this crossover randomized controlled trial (RCT), the effect of optimal CV stimulation and sham stimulation on BP and orthostatic symptoms will be assessed and compared.
The information gleaned from this work will allow design and implementation of scTS interventions in the early phase following an SCI, allowing full participation in inpatient rehabilitation programs, which are often hindered by the patients' autonomic dysfunction.
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Trauma, Nervous System, Nervous System Diseases, Central Nervous System Diseases, Hypotension
- Being tested
- Orthostatic challenge, Biostim-5 transcutaneous spinal stimulation - Mapping, Biostim-5 transcutaneous spinal stimulation - "Optimal" testing, Biostim-5 transcutaneous spinal stimulation - "Sham" testing
- Keywords
- Transcutaneous Spinal Cord Stimulation, Spinal stimulation, Orthostatic Hypotension, Blood Pressure, Neuromodulation, Acute spinal cord injury, Hypotension, Acute inpatient rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases, Trauma, Nervous System, Nervous System Diseases, Central Nervous System Diseases, Hypotension, Hypotension, Orthostatic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthostatic challengeDiagnostic test
Also called Sit-up test
Designed to invoke an orthostatic response. It begins with the participants lying supine on a specialized bed. The bed is then converted into a chair by raising the head of the bed by 90° and dropping the base of the bed by 90° from the knee.
This position will be maintained for 15 minutes, while hemodynamic measures are continuously recorded. Some of these sessions will be accompanied by spinal stimulation.
Biostim-5 transcutaneous spinal stimulation - MappingDevice
Transcutaneous stimulation of the spinal cord. Two days of mapping will be performed to determine sites for modulation of blood pressure. During each day, with the participant in a supine or seated position, electrodes will be placed on the midline of one of the following spinous processes: C3/4, C5/6, C7/T1, T7/8, T11/12, L1/2 and S1/2. Stimulation intensity will start at 5 mA and gradually increase by 5 mA increments up to 100 mA. The frequency will be two or 30 Hz.
Biostim-5 transcutaneous spinal stimulation - "Optimal" testingDevice
Based on the mapping sessions, profiles will be established to guide the selection of an optimal site location for blood pressure modulation (within the range of 110-120 mmHg).
Biostim-5 transcutaneous spinal stimulation - "Sham" testingDevice
Based on the mapping sessions, a profile that does not elicit a significant blood pressure response, will be used for the sham stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Optimal stimulation (for a blood pressure response) | Active comparator | Stimulation will be applied during an orthostatic sit-up challenge, using the profile (stimulation site and parameters) that was chosen in the mapping sessions, for optimal modulation of systolic blood pressure. Receives: Diagnostic Test: Orthostatic challenge; Device: Biostim-5 transcutaneous spinal stimulation - Mapping; Device: Biostim-5 transcutaneous spinal stimulation - "Optimal" testing |
| Sham stimulation | Sham comparator | Sham stimulation will be applied during an orthostatic sit-up challenge. Sham stimulation will be delivered at a predetermined spinal location. Stimulation parameters, however, will be different from those chosen for the optimal stimulation, and sensation may be different as well. Receives: Diagnostic Test: Orthostatic challenge; Device: Biostim-5 transcutaneous spinal stimulation - Mapping; Device: Biostim-5 transcutaneous spinal stimulation - "Sham" 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 2 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 2 weeks
Systolic blood pressure measurements (mmHg) - Mean and SD of beat-to-beat BP
A comparison of systolic blood pressure with no stimulation, sham or optimal stimulation during an orthostatic challenge will be performed to assess the efficacy of stimulation.
Measured: Throughout the experiment, average of 2 weeks
Change in Orthostatic symptoms when stimulation is applied
A questionnaire ranking the severity of orthostatic symptoms (dizziness, nausea), using a scale of 1-10 (10 being the most severe), will be conducted during an orthostatic test to assess the efficacy of stimulation and compare the effects of optimal and sham stimulation.
Measured: Will be performed every 5 minutes during the orthostatic tests, average of 2 weeks
Secondary outcomes (8)
Numeric Rating Scale (NRS) for pain
Adverse effects will be recorded to assess the safety of stimulation. A numerical scale of 0 to 10 (with 10 meaning the worst pain) will be used to monitor any pain symptoms associated with the stimulation
Measured: Throughout the experiment, average of 2 weeks
Skin integrity assessment
Adverse effects will be recorded to assess the safety of stimulation. Skin integrity (skin irritation or breakdown caused by electrodes, wires or adhesive tape) will be assessed on a daily basis
Measured: Throughout the experiment, average of 2 weeks
Feasibility of applying scTS in inpatient settings - compliance
The ratio of total number of completed sessions divided by the number of sessions initially planned.
Measured: Throughout the experiment, average of 2 weeks
Feasibility of applying scTS in inpatient settings - session duration
The length of time of each session and total length will be recorded.
Measured: Throughout the experiment, average of 2 weeks
Feasibility of applying scTS in inpatient settings - effect on therapy
Total therapy time during inpatient rehabilitation will be recorded to ensure there is no interruption to the normal therapy schedule.
Measured: Throughout the experiment, average of 2 weeks
Electromyography (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, ensuring that BP response was not due to lower limb muscle contraction
Measured: Through Mapping and testing sessions, average of 2 weeks
Additional hemodynamic measure - diastolic blood pressure
These measures will be collected on a daily basis throughout the trial
Measured: throughout the trial, average of 2 weeks
Additional hemodynamic measure - heart rate
These measures will be collected on a daily basis throughout the trial
Measured: throughout the trial, average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Dec 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 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
- Randomised
- Intervention model
- Crossover
- Model description
- Twelve individuals admitted to inpatient rehabilitation after sustaining a spinal cord injury will be enrolled. They will complete baseline assessments including an orthostatic sit-up test and neurophysiological mapping. Subsequently, the intervention will consist of two days of stimulation mapping to locate the optimal spinal segment for a blood pressure response. Participants will then be randomly assigned to two groups that would determine the order of the two testing days (optimal/sham), where stimulation is applied during an orthostatic test.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 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
- NCT05731986
- Sponsor's protocol ID
- CSCR23FEL002
- Other IDs
- CSCR23FEL002
- 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 Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study
- ClinicalTrials.gov ID
- NCT05731986
- Acronym / sponsor ID
- SCI / CSCR23FEL002
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Trauma, Nervous System, Nervous System Diseases, Central Nervous System Diseases, Hypotension
- Keywords
- Transcutaneous Spinal Cord Stimulation, Spinal stimulation, Orthostatic Hypotension, Blood Pressure, Neuromodulation, Acute spinal cord injury, Hypotension, Acute inpatient rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 16 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.
The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period.
The main questions it aims to answer are:
- Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared.
- What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg?
Participants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.
Detailed description
Blood pressure (BP) control in persons with a spinal cord injury (SCI) is often impaired, resulting in short and long-term health complications and a decline in quality of life. Cardiovascular (CV) dysfunction develops early after SCI and often continues a lifetime. Orthostatic hypotension (OH), a 20/10 mmHg decrease in systolic/diastolic BP when moving from a supine to an upright position, is especially prevalent in the early phase, and frequently accompanied by symptoms of dizziness, weakness, fatigue, and syncope. Affecting up to 75% of therapy treatments during inpatient rehabilitation, OH significantly interferes with participation during the critical rehab time-period, especially as length of stay in rehabilitation has substantially shortened in the past decades.
The compelling rationale for early identification and treatment of OH is met by several pharmacological and non-pharmacological interventions, however, the majority have limited effect, and increase the risk of adverse drug effects due to polypharmacy. In recent years, epidural and transcutaneous spinal cord stimulation has been explored with promising results as a potential treatment to CV dysfunction in SCI. To date, only individuals with a chronic SCI (>1 year) were included in these studies.
The objective of this study is to investigate the effect of spinal cord transcutaneous stimulation (scTS) on BP in individuals with an acute/sub-acute SCI (7-30 days after injury), during their inpatient rehabilitation. Optimal stimulation sites and parameters that increase and stabilize systolic BP (SBP) within the normotensive range (110-120 mmHg) during an orthostatic challenge will be sought. In this crossover randomized controlled trial (RCT), the effect of optimal CV stimulation and sham stimulation on BP and orthostatic symptoms will be assessed and compared.
The information gleaned from this work will allow design and implementation of scTS interventions in the early phase following an SCI, allowing full participation in inpatient rehabilitation programs, which are often hindered by the patients' autonomic dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Twelve individuals admitted to inpatient rehabilitation after sustaining a spinal cord injury will be enrolled. They will complete baseline assessments including an orthostatic sit-up test and neurophysiological mapping. Subsequently, the intervention will consist of two days of stimulation mapping to locate the optimal spinal segment for a blood pressure response. Participants will then be randomly assigned to two groups that would determine the order of the two testing days (optimal/sham), where stimulation is applied during an orthostatic test.
| Arm | Type | Receives |
|---|---|---|
| Optimal stimulation (for a blood pressure response) | Active comparator | Diagnostic Test: Orthostatic challenge, Device: Biostim-5 transcutaneous spinal stimulation - Mapping, Device: Biostim-5 transcutaneous spinal stimulation - "Optimal" testingStimulation will be applied during an orthostatic sit-up challenge, using the profile (stimulation site and parameters) that was chosen in the mapping sessions, for optimal modulation of systolic blood pressure. |
| Sham stimulation | Sham comparator | Diagnostic Test: Orthostatic challenge, Device: Biostim-5 transcutaneous spinal stimulation - Mapping, Device: Biostim-5 transcutaneous spinal stimulation - "Sham" testingSham stimulation will be applied during an orthostatic sit-up challenge. Sham stimulation will be delivered at a predetermined spinal location. Stimulation parameters, however, will be different from those chosen for the optimal stimulation, and sensation may be different as well. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 7-30 days after injury
- Injury level ≥T2 (thoracic level)
- American Spinal Injury Association Impairment Scale (AIS) A-C
- Exhibits at least one of the following hypotensive symptoms:
Key exclusion criteria (10 listed)
- Current illness (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the intervention, etc.) or infection
- 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 |
|---|---|---|
| Orthostatic challengeAlso: Sit-up testDesigned to invoke an orthostatic response. It begins with the participants lying supine on a specialized bed. The bed is then converted into a chair by raising the head of the bed by 90° and dropping the base of the bed by 90° from the knee. This position will be maintained for 15 minutes, while hemodynamic measures are continuously recorded. Some of these sessions will be accompanied by spinal stimulation. | Diagnostic test | Optimal stimulation (for a blood pressure response), Sham stimulation |
| Biostim-5 transcutaneous spinal stimulation - MappingTranscutaneous stimulation of the spinal cord. Two days of mapping will be performed to determine sites for modulation of blood pressure. During each day, with the participant in a supine or seated position, electrodes will be placed on the midline of one of the following spinous processes: C3/4, C5/6, C7/T1, T7/8, T11/12, L1/2 and S1/2. Stimulation intensity will start at 5 mA and gradually increase by 5 mA increments up to 100 mA. The frequency will be two or 30 Hz. | Device | Optimal stimulation (for a blood pressure response), Sham stimulation |
| Biostim-5 transcutaneous spinal stimulation - "Optimal" testingBased on the mapping sessions, profiles will be established to guide the selection of an optimal site location for blood pressure modulation (within the range of 110-120 mmHg). | Device | Optimal stimulation (for a blood pressure response) |
| Biostim-5 transcutaneous spinal stimulation - "Sham" testingBased on the mapping sessions, a profile that does not elicit a significant blood pressure response, will be used for the sham stimulation. | Device | Sham stimulation |
Primary outcome
Optimal stimulation sites
Time frame: Through Mapping and testing sessions, average of 2 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 2 weeks
Identify scTS frequency that restores systolic BP within the normotensive range (110-120 mmHg).
Systolic blood pressure measurements (mmHg) - Mean and SD of beat-to-beat BP
Time frame: Throughout the experiment, average of 2 weeks
A comparison of systolic blood pressure with no stimulation, sham or optimal stimulation during an orthostatic challenge will be performed to assess the efficacy of stimulation.
Change in Orthostatic symptoms when stimulation is applied
Time frame: Will be performed every 5 minutes during the orthostatic tests, average of 2 weeks
A questionnaire ranking the severity of orthostatic symptoms (dizziness, nausea), using a scale of 1-10 (10 being the most severe), will be conducted during an orthostatic test to assess the efficacy of stimulation and compare the effects of optimal and sham stimulation.
8 secondary outcomes
Numeric Rating Scale (NRS) for pain
Time frame: Throughout the experiment, average of 2 weeks
Skin integrity assessment
Time frame: Throughout the experiment, average of 2 weeks
Feasibility of applying scTS in inpatient settings - compliance
Time frame: Throughout the experiment, average of 2 weeks
Feasibility of applying scTS in inpatient settings - session duration
Time frame: Throughout the experiment, average of 2 weeks
Feasibility of applying scTS in inpatient settings - effect on therapy
Time frame: Throughout the experiment, average of 2 weeks
Electromyography (EMG) of leg muscles - muscle activation (analysis of mean and peak amplitudes)
Time frame: Through Mapping and testing sessions, average of 2 weeks
Additional hemodynamic measure - diastolic blood pressure
Time frame: throughout the trial, average of 2 weeks
Additional hemodynamic measure - heart rate
Time frame: throughout the trial, average of 2 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 Orthostatic challenge, Biostim-5 transcutaneous spinal stimulation - Mapping and Biostim-5 transcutaneous spinal stimulation - "Optimal" testing in people with Spinal Cord Injuries and Spinal Cord Diseases, 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 10 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. 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?
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 2 weeks). The study lists 4 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.