NCT06861790 · University of Florida
WISE-2B Brain Study (Weight Loss Intervention Surgical Effects on Brain Function)
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
tVNS
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.
PROCEDURE
Complete Vagotomy
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.
PROCEDURE
Anterior Vagotomy
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.
Primary outcome measures
Brain inflammation - MRS
Time frame: 18 months
Utilizing MRS the study seeks to understand changes in brain inflammation between the groups
Cognitive functioning - Global functioning score
Time frame: 18 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Gainesville, Florida
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2026 · Source of record for eligibility and locations