University of Florida
The goal of the study to understand the effects of weight loss and improvements in diabetes following bariatric surgery on brain function and thinking. This study will also examine whether non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention initiated 30 days post-surgery improves brain function and thinking. The study does NOT cover any costs associated with bariatric surgery.
There will be one group of study participants. The group will (independently of this research study) have weight loss surgery to help them with weight loss. All research participants in this group will be tested on thinking and memory processes at the start of the study, after 12 weeks, and again at 18 months. They will also undergo a non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention days post-surgery, for 30 days at home with the device that is provided. The group will have an MRI Brain Scan at each time-point to study the changes in the structure and function of the…
Inclusion Criteria: * Between age: 20-75 yrs, English speaking, Physically mobile * Body Mass Index (BMI) \>35 kg before surgery * Compatible of MRI Scanning * Willing to give a small blood sample * Capable of providing informed consent Exclusion Criteria: * Prior or current neurological disorder * Major psychiatric disturbance * Unstable medical conditions (cancer) * MRI contraindications (claustrophobia, metal implants, waist/torso circumference)
Though we will be utilizing a tVNS (Transcutaneous Vegus Nerve Stimulation) device this study is not a device study. The device being used is being done so under its approved usage. The intervention utilizes a non-invasive process to stimulate the Vagus nerve using very small electrical currents. This intervention is completed daily for one month.
Participants will not be receiving bariatric surgery as an intervention of this study. Instead, the study will enroll patients already planning on undergoing the surgery. The surgeon will utilize one of two surgical approaches which will be observed in this study.
Participants will not be receiving bariatric surgery as an intervention of this study. Instead, the study will enroll patients already planning on undergoing the surgery. The surgeon will utilize one of two surgical approaches which will be observed in this study.
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