Direct Carotid Sinus Nerve Stimulation in Anesthetized Human Subjects

NCT06969846 | Completed

• 1 other identifier: CLINB0001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

neuromodulation; hypertension; autonomic; electrode; implant

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour

Secondary Outcomes (3)

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

  1 hour

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

  1 hour

• Cumulative drops in SBP throughout entire stimulation session

  1 hour

Study Arms (1)

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).

Device: CSN electrode was implanted around tissue including CSN branches

Interventions

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.

Surgical Therapeutic Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead

Study Sites (1)

VA Northeast Ohio Healthcare System

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 40691692 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of Otolaryngology-Head & Neck Surgery

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: May 14, 2025
• Study Start: April 3, 2020
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

US (1)