WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)
Recruiting · NCT06861790 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Florida
View the official record on ClinicalTrials.gov →Interventions studied
Anterior VagotomyComplete VagotomytVNS
What this trial is about
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.
Who can take part
Age range
20 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- University of Florida - College of Public Health and Health Professions - Gainesville, Florida, United States