Direct Carotid Sinus Nerve Stimulation in Anesthetized Human Subjects

Cleveland VA Medical Research and Education Foundation

Status: Completed

Conditions: Blood Pressure Management; HTN-Hypertension

Treatments: Device: CSN electrode was implanted around tissue including CSN branches

Study type: Interventional

Funder types: Other

Identifiers

NCT06969846

CLINB0001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Surgical Therapeutic Group

Experimental group

Description:

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).

Treatment:

Device: CSN electrode was implanted around tissue including CSN branches