88
Participants
Start Date
December 20, 2021
Primary Completion Date
February 1, 2027
Study Completion Date
February 1, 2027
Galantamine
4mg daily titrating up to 8mg twice a day
Placebo
1 pill a day for 4 weeks, 2 pills a day for 8 weeks
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.
RECRUITING
Chaney Johnson, Nashville
Vanderbilt University Medical Center
OTHER