Clinical Trials Directory

Trials / Completed

CompletedNCT06969846

Direct Carotid Sinus Nerve Stimulation in Anesthetized Human Subjects

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
18 (actual)
Sponsor
Louis Stokes VA Medical Center · Federal
Sex
All
Age
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DEVICECSN electrode was implanted around tissue including CSN branchesUsing 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.

Timeline

Start date
2020-04-03
Primary completion
2022-08-12
Completion
2024-08-12
First posted
2025-05-14
Last updated
2025-05-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06969846. Inclusion in this directory is not an endorsement.