Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

December 20, 2021

Primary Completion Date

February 1, 2027

Study Completion Date

February 1, 2027

Conditions
Endothelial Dysfunction
Interventions
DRUG

Galantamine

4mg daily titrating up to 8mg twice a day

DRUG

Placebo

1 pill a day for 4 weeks, 2 pills a day for 8 weeks

DEVICE

TENS 7000

The FDA-approved TENS 7000 device will be used for Trans-auricular vagus nerve stimulation (TaVNS) during a period of enhanced vascular oxidative stress. This device will be supplemented with ear clip electrodes. The site of the stimulation for such electrodes are the tragus or concha. The device will have built in safety controls to minimize additional risks to the subjects (as per FDA guidance on stimulators). We will use typical stimulation conditions (30 Hz, 300 µs) and amplitude dependent on perception threshold.

Trial Locations (1)

37232

RECRUITING

Chaney Johnson, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER