How weight-loss surgery and vagal nerve stimulation affect thinking and the brain
Official title: Obesity and Type 2 Diabetes: Bariatric Surgery Effects on Brain Function -Part 2 (WISE-2B Brain Study)
Run by University of Florida · NCT06861790 · Data updated 2026-11-12
We will test whether weight-loss surgery and a 30-day at-home vagal nerve stimulation (tVNS) treatment improve thinking and brain function in adults with obesity and diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 75 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | November 10, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT06861790 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20–75 with BMI over 35 who are planning or scheduled for bariatric surgery, can have MRI scans, speak English, are physically mobile, and can provide informed consent and blood samples.
✕Probably not a fit
People with prior or current neurological disorders, major psychiatric disturbances, unstable medical conditions (such as active cancer), or MRI contraindications are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults who are independently undergoing bariatric surgery will be enrolled and tested before surgery, at 12 weeks, and again at 18 months to track changes in thinking, memory, and brain function. At each time point participants will receive an MRI brain scan and blood tests for glucose and protein markers, and will complete cognitive testing. Starting 30 days after surgery, participants will use a provided non-invasive tVNS device at home for 30 days to see if this adds benefit for brain function. The protocol includes one cohort and records surgical details such as type of vagotomy when applicable to relate surgical changes to brain and metabolic outcomes.
Why it matters
Potential benefit: If successful, the approach could show ways that weight loss and short-term tVNS improve memory and thinking and identify biological markers linked to those changes.
How similar studies have gone: Previous research has shown bariatric surgery often produces metabolic and cognitive improvements, while non-invasive tVNS is a newer, experimental approach with mixed early evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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University of Florida - College of Public Health and Health Professions
Gainesville, Florida, United States Recruiting
Study contacts
- Principal investigator: Eric Porges, PhD — University of Florida
- Study coordinator: Keyanni J Johnson
- Email: kjjohnson@ufl.edu
- Phone: 3522945618
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.