WISE-2B Brain Study: Weight Loss Surgery and Brain Function

This study, called WISE-2B, aims to understand how weight loss and improvements in diabetes after bariatric (weight loss) surgery affect your brain function and thinking. Researchers are also looking at whether a non-invasive treatment called transcutaneous vagal nerve stimulation (tVNS), which uses small electrical currents to stimulate a nerve, can improve brain function after surgery. You could join if you are between 20 and 75 years old, speak English, are physically mobile, have a BMI over 35 before surgery, and are already planning to have bariatric surgery. The study will measure brain inflammation and your thinking abilities 18 months after surgery to see if these improve. The study status is currently unclear.

Study design
This is an interventional study with one group of participants, aiming to enroll 120 people. It is not specified if the study is randomized or blinded.
What's involved
You will have tests for thinking and memory at the start, after 12 weeks, and again at 18 months. You will also use a tVNS device at home for 30 days after surgery and have MRI brain scans and blood tests at each time point.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 18 months after surgery, with primary endpoints measured at this time.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06861790

WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)

Recruiting
NAAges 20–75Interventional
University of Florida
~120 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:tVNSComplete VagotomyAnterior Vagotomy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brain inflammation - MRS
Measured over 18 months
+1 more outcome measured
Diabetes
Weight Loss
1 sites across 1 states
Florida1
  • Eric Porges, PhD · PRINCIPAL_INVESTIGATOR · University of Florida

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Eligibility criteria

Inclusion

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

Prior or current neurological disorder
Major psychiatric disturbance
Unstable medical conditions (cancer)
MRI contraindications (claustrophobia, metal implants, waist/torso circumference)
  • Brain inflammation - MRS18 months

    Utilizing MRS the study seeks to understand changes in brain inflammation between the groups

  • Cognitive functioning - Global functioning score18 months

    Utilizing a battery of cognitive tests the study seeks to determine changes in cognitive functioning. This can be determined by computing the Global functioning score on the battery of measures.