Direct Carotid Sinus Nerve Stimulation in Anesthetized Human Subjects

Louis Stokes VA Medical Center18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HTN-Hypertension Blood Pressure Management

Interventions

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

VA Northeast Ohio Healthcare System

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 hour

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 1 hour

Data from ClinicalTrials.gov

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