Direct Carotid Sinus Nerve Stimulation in Anesthetized Human Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-03

Study Completion Date

2024-08-12

Brief Summary

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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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Detailed Description

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Conditions

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HTN-Hypertension Blood Pressure Management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical Therapeutic Group

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).

Group Type EXPERIMENTAL

CSN electrode was implanted around tissue including CSN branches

Intervention Type 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.

Interventions

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CSN electrode was implanted around tissue including CSN branches

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.

Intervention Type DEVICE

Eligibility Criteria

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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).

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes