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Direct Carotid Sinus Nerve Stimulation in Anesthetized Human Subjects

NCT06969846 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-05-14

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Louis Stokes VA Medical Center

    lead FED

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-03
Primary Completion
2022-08-12
Completion
2024-08-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06969846 on ClinicalTrials.gov