Nerve Stimulation for Weight Loss and Diabetes

Recruiting in Palo Alto (17 mi)

Overseen byEric Porges, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Florida

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

The WISE-2B Brain Study is for individuals aged 20-75 with severe weight issues (BMI over 35) who are about to undergo bariatric surgery. Participants must be able to have an MRI scan, provide a blood sample, speak English, and move around on their own. People with claustrophobia, metal implants that affect MRI, neurological disorders, major psychiatric conditions or unstable medical situations like cancer cannot join.

Inclusion Criteria

My BMI was over 35 kg/m2 before surgery.

Compatible with MRI Scanning

Willing to give a small blood sample

+2 more

Exclusion Criteria

MRI contraindications (claustrophobia, metal implants, waist/torso circumference)

Prior or current neurological disorder

Major psychiatric disturbance

+1 more

Participant Groups

This study examines how brain function and thinking are affected by weight loss and diabetes improvement after bariatric surgery. It also tests if starting non-invasive transcutaneous vagal nerve stimulation (tVNS) therapy 30 days post-surgery can further improve cognitive functions. The cost of the surgery itself isn't covered by the study.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: tVNS + complete vagotomyExperimental Treatment2 Interventions

This arm will receive transcutaneous vagus nerve stimulation and a complete vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery

Group II: tVNS + anterior vagotomyExperimental Treatment2 Interventions

This arm will receive transcutaneous vagus nerve stimulation and an anterior vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery.

Group III: Sham + complete vagotomyPlacebo Group1 Intervention

This arm will not receive transcutaneous vagus nerve stimulation and will receive a complete vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery.

Group IV: Sham + anterior vagotomyPlacebo Group1 Intervention

This arm will not receive transcutaneous vagus nerve stimulation and will receive an anterior vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery.