Direct Carotid Sinus Nerve Stimulation in Anesthetized Human Subjects

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.

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Key information

Conditions

HTN-Hypertension Blood Pressure Management Cardiovascular Diseases Hypertension Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Northeast Ohio Healthcare System

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

. 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

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).

Treatment and study plan

CSN electrode was implanted around tissue including CSN branches

Device

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.

Primary outcomes

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.

Secondary outcomes

The changes in blood pressure as a result of stimulation across all stimulation epochs

Time frame: 1 hour

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.
The changes in heart rate as a result of stimulation across all stimulation epochs

Time frame: 1 hour

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.
Cumulative drops in SBP throughout entire stimulation session

Time frame: 1 hour

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.

Sponsors and collaborators

Lead sponsor

Louis Stokes VA Medical Center

Fed

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2024
First posted: May 14, 2025
Registry last updated: May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed