Recruiting

tVNS

Sponsor:

University of Florida

Code:

NCT06861790

Conditions

Diabetes

Weight Loss

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

tVNS

Complete Vagotomy

Anterior Vagotomy

Study Details

Brief summary:

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.

Conditions

Diabetes

Weight Loss

Study ID

NCT06861790

Start date

Nov 10, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: tVNS + anterior vagotomy

This arm will receive transcutaneous vagus nerve stimulation and an anterior vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery.

experimental: tVNS + complete vagotomy

This arm will receive transcutaneous vagus nerve stimulation and a complete vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery

sham comparator: Sham + anterior vagotomy

This arm will not receive transcutaneous vagus nerve stimulation and will receive an anterior vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery.

sham comparator: Sham + complete vagotomy

This arm will not receive transcutaneous vagus nerve stimulation and will receive a complete vagotomy during their bariatric surgery. Note a vagotomy is standard practice during bariatric surgery.

Interventions

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.

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.

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 measure

  • Brain inflammation - MRS [ Time Frame: 18 months ]
  • Cognitive functioning - Global functioning score [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Keyanni J Johnson

3522945618kjjohnson@ufl.edu

Ronald Cohen, PhD

352-295-5840roncohen@ufl.edu

Locations

University of Florida - College of Public Health and Health Professions

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Keyanni Johnson

352-294-5816kjjohnson@ufl.edu

Principal Investigator:

Ronald Cohen, PhD

More Information

Sponsor

University of Florida

Last update posted

Feb 10, 2026

Last verified

Dec, 2025

Keywords

  • Weight loss and brain function
  • Effects of bariatric surgery on brain function
  • Reduced glucose insulin changes and brain function
  • tVNS intervention post-surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-02-10.