HTN-HypertensionNCT06969846
Direct Carotid Sinus Nerve Stimulation in Anesthetized Human Subjects
A study testing CSN electrode was implanted around tissue including CSN branches in people with HTN-Hypertension and Blood Pressure Management, run by Louis Stokes VA Medical Center at 1 site in United States.
Trial summary
Uncontrolled hypertension (HTN) is growing in incidence globally creating a critical need for alternative therapeutic strategies. Directly stimulating the carotid sinus nerve (CSN) is known to potentially reduce blood pressure (BP) but its clinical efficacy has not been consistently demonstrated with existing… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HTN-Hypertension, Blood Pressure Management
- What is being tested?
- CSN electrode was implanted around tissue including CSN branches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2020to 12 Aug 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- . Eligible patients were those scheduled to undergo elective surgical procedure that therapeutically indicated exposure of the carotid bifurcation and vascular sheath (e.g. carotid endarterectomy, neck dissection, or carotid tumor Resection) regardless of a HTN diagnosis.
Who cannot join
- history of stroke
- prior ipsilateral neck surgery or radiation treatment
- Cardiovascular disease that precluded enrollment were diagnoses which independently increased surgical and anesthetic risk (American Society for Anesthesia Classification System).
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Northeast Ohio Healthcare System
Cleveland, Ohio, 44106
About this study
Uncontrolled hypertension (HTN) is growing in incidence globally creating a critical need for alternative therapeutic strategies. Directly stimulating the carotid sinus nerve (CSN) is known to potentially reduce blood pressure (BP) but its clinical efficacy has not been consistently demonstrated with existing electrode technologies in humans.
We investigated the effect of acute direct CSN stimulation on BP and HR in anesthetized humans using an application-specific multi-contact electrode.
- Conditions
- HTN-Hypertension, Blood Pressure Management
- Being tested
- CSN electrode was implanted around tissue including CSN branches
- Keywords
- neuromodulation, hypertension, autonomic, electrode, implant
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSN electrode was implanted around tissue including CSN branchesDevice
Using a novel surgical approach, a custom electrode was implanted around tissue including CSN branches in anesthetized adults. Following functional mapping, presumed baroafferent fibers were identified via response and stimulated. Outcome measures included change in systolic BP (SBP), diastolic BP (DBP), and heart rate (HR) during and after stimulation using multi-level modeling. Secondarily, dose dependency was examined.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Therapeutic Group | Experimental | Eligible patients were those scheduled to undergo elective surgical procedure that therapeutically indicated exposure of the carotid bifurcation and vascular sheath (e.g. carotid endarterectomy, neck dissection, or carotid tumor Resection) regardless of a HTN diagnosis. Exclusion criteria included disease states such as a history of stroke, or prior ipsilateral neck surgery or radiation treatment. Cardiovascular disease that precluded enrollment were diagnoses which independently increased surgical and anesthetic risk (American Society for Anesthesia Classification System). Receives: Device: CSN electrode was implanted around tissue including CSN branches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum drops and recovery in systolic blood pressure (SBP) as a result of carotid sinus nerve (CSN) stimulation
The primary outcome was maximum drops and recovery in systolic blood pressure (SBP) as a function of carotid sinus nerve (CSN) stimulation as measured in mmHg. The maximum drop was calculated as the maximum change in SBP while stimulus was active, relative to the baseline value 30 seconds before starting stimulus. Maximum recovery was calculated as the largest change in SBP within 30 seconds of ending stimulus relative to the nadir in SBP (mmHg) during stimulation.
Measured: 1 hour
Secondary outcomes (3)
The changes in blood pressure as a result of stimulation across all stimulation epochs
The generalized drops and recoveries of systolic and diastolic blood pressure (SBP \& DBP) measured in mmHg across all stimulation epochs as a function of CSN stimulation and stimulation withdrawal using the same timeframe as that used in the primary outcome.
Measured: 1 hour
The changes in heart rate as a result of stimulation across all stimulation epochs
The generalized drops and recoveries in heart rate (HR) measured in beats per minute (BPM) as a result of stimulation and stimulation withdrawal across all stimulation epochs using the same time frame as #1.
Measured: 1 hour
Cumulative drops in SBP throughout entire stimulation session
Individual patient cumulative drops in SBP (measured in mmHg) throughout the entire stimulation period/session were measured by pooling the baseline SBP values before the stimulation session began and the final SBP following the completion of the last stimulation epoch of the period.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start3 Apr 2020
- Primary completion12 Aug 2022
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HTN-HypertensionStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jonathan Baskin, Louis Stokes VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969846
- Sponsor's protocol ID
- CLINB0001
- Other IDs
- CLINB0001
- Status last verified
- May 2025
- First submitted
- 4 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Majerus SJA, Pinault G, Tyler D, Dunning J, Schlesinger R, Heald E, Baskin JZ. Direct carotid sinus nerve stimulation in anesthetized human subjects. Sci Rep. 2025 Jul 21;15(1):26488. doi: 10.1038/s41598-025-10091-1.
PubMed 40691692
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Carotid Sinus Nerve Stimulation in Anesthetized Human Subjects
- ClinicalTrials.gov ID
- NCT06969846
- Acronym / sponsor ID
- CLINB0001
- Conditions
- HTN-Hypertension, Blood Pressure Management
- Keywords
- neuromodulation, hypertension, autonomic, electrode, implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 14 May 2025 (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.
Uncontrolled hypertension (HTN) is growing in incidence globally creating a critical need for alternative therapeutic strategies. Directly stimulating the carotid sinus nerve (CSN) is known to potentially reduce blood pressure (BP) but its clinical efficacy has not been consistently demonstrated with existing electrode technologies in humans.
We investigated the effect of acute direct CSN stimulation on BP and HR in anesthetized humans using an application-specific multi-contact electrode.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Therapeutic Group | Experimental | Device: CSN electrode was implanted around tissue including CSN branchesEligible patients were those scheduled to undergo elective surgical procedure that therapeutically indicated exposure of the carotid bifurcation and vascular sheath (e.g. carotid endarterectomy, neck dissection, or carotid tumor Resection) regardless of a HTN diagnosis. Exclusion criteria included disease states such as a history of stroke, or prior ipsilateral neck surgery or radiation treatment. Cardiovascular disease that precluded enrollment were diagnoses which independently increased surgical and anesthetic risk (American Society for Anesthesia Classification System). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- . Eligible patients were those scheduled to undergo elective surgical procedure that therapeutically indicated exposure of the carotid bifurcation and vascular sheath (e.g. carotid endarterectomy, neck dissection, or carotid tumor Resection) regardless of a HTN diagnosis.
Key exclusion criteria (3 listed)
- history of stroke
- prior ipsilateral neck surgery or radiation treatment
- Cardiovascular disease that precluded enrollment were diagnoses which independently increased surgical and anesthetic risk (American Society for Anesthesia Classification System).
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 |
|---|---|---|
| CSN electrode was implanted around tissue including CSN branchesUsing a novel surgical approach, a custom electrode was implanted around tissue including CSN branches in anesthetized adults. Following functional mapping, presumed baroafferent fibers were identified via response and stimulated. Outcome measures included change in systolic BP (SBP), diastolic BP (DBP), and heart rate (HR) during and after stimulation using multi-level modeling. Secondarily, dose dependency was examined. | Device | Surgical Therapeutic Group |
Primary outcome
Maximum drops and recovery in systolic blood pressure (SBP) as a result of carotid sinus nerve (CSN) stimulation
Time frame: 1 hour
The primary outcome was maximum drops and recovery in systolic blood pressure (SBP) as a function of carotid sinus nerve (CSN) stimulation as measured in mmHg. The maximum drop was calculated as the maximum change in SBP while stimulus was active, relative to the baseline value 30 seconds before starting stimulus. Maximum recovery was calculated as the largest change in SBP within 30 seconds of ending stimulus relative to the nadir in SBP (mmHg) during stimulation.
3 secondary outcomes
The changes in blood pressure as a result of stimulation across all stimulation epochs
Time frame: 1 hour
The changes in heart rate as a result of stimulation across all stimulation epochs
Time frame: 1 hour
Cumulative drops in SBP throughout entire stimulation session
Time frame: 1 hour
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 14 May 2025.
- Derived from this study: PubMed 40691692Majerus SJA, Pinault G, Tyler D, Dunning J, Schlesinger R, Heald E, Baskin JZ. Direct carotid sinus nerve stimulation in anesthetized human subjects. Sci Rep. 2025 Jul 21;15(1):26488. doi: 10.1038/s41598-025-10091-1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSN electrode was implanted around tissue including CSN branches in people with HTN-Hypertension and Blood Pressure Management, run by Louis Stokes VA Medical Center 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 1 inclusion and 3 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 14 May 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?
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?
Maximum drops and recovery in systolic blood pressure (SBP) as a result of carotid sinus nerve (CSN) stimulation (time frame: 1 hour). 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 NCT06969846, 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 14 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.