TrialGlobe

Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06861790

Recruiting nowNot applicableInterventional

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 75 Years
SexAll
Healthy volunteersAccepted
ConditionDiabetes, Weight Loss

Full registry 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)

Treatments and study arms

tVNS

Behavioral

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.

Complete Vagotomy

Procedure

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.

Anterior Vagotomy

Procedure

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 outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Florida - College of Public Health and Health Professions🇺🇸 Gainesville, Florida, United States
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Keyanni JohnsonContact
Email · Call 352-294-5816
Ronald Cohen, PhDPrincipal Investigator
Eric Porges, PhDSub Investigator