Nerve Stimulation for Weight Loss and Diabetes

Overseen By Ronald Cohen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Neurological, Psychiatric, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Anterior Vagotomy, Complete Vagotomy, tVNS for weight loss and diabetes?

Research shows that vagotomy, a procedure that involves cutting the vagus nerve, can lead to weight loss in both animals and humans by reducing hunger and changing food intake habits. Some studies have observed significant weight decreases in patients with morbid obesity after vagotomy, suggesting it may help with weight management. ^{1 2 3 4 5}

Is nerve stimulation for weight loss and diabetes safe for humans?

Nerve stimulation, including vagotomy, has been studied for various conditions and is generally considered safe, though some adverse events have been reported. In children, some experienced treatable side effects, and in adults, there were few complications, with one case of sudden death years after the procedure. Overall, it is tolerated well, but unforeseen surgeries may be needed. ^{1 2 3 6 7}

How does the treatment Anterior Vagotomy, Complete Vagotomy differ from other treatments for weight loss and diabetes?

Anterior Vagotomy, Complete Vagotomy is unique because it involves cutting the vagus nerve, which can lead to weight loss by reducing hunger and altering food intake, unlike other treatments that may focus on diet, exercise, or medication. This approach is based on its effects on digestion and hormonal changes, which are not typically targeted by standard weight loss or diabetes treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Eric Porges, PhD

Principal Investigator

University of Florida

Eligibility Criteria

The WISE-2B Brain Study is for individuals aged 20-75 with severe weight issues (BMI over 35) who are about to undergo bariatric surgery. Participants must be able to have an MRI scan, provide a blood sample, speak English, and move around on their own. People with claustrophobia, metal implants that affect MRI, neurological disorders, major psychiatric conditions or unstable medical situations like cancer cannot join.

Inclusion Criteria

My BMI was over 35 kg/m2 before surgery.

Compatible with MRI Scanning

Willing to give a small blood sample

Exclusion Criteria

MRI contraindications (claustrophobia, metal implants, waist/torso circumference)

Prior or current neurological disorder

Major psychiatric disturbance

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Assessment

Participants undergo bariatric surgery and initial cognitive and MRI assessments

1 week

1 visit (in-person)

tVNS Intervention

Participants receive non-invasive transcutaneous vagal nerve stimulation for 30 days post-surgery

4 weeks

Home-based intervention

Follow-up Assessments

Participants are assessed on cognitive and brain function at 12 weeks and 18 months post-surgery

18 months

2 visits (in-person)

Treatment Details

Interventions

• Anterior Vagotomy
• Complete Vagotomy
• tVNS

Trial Overview This study examines how brain function and thinking are affected by weight loss and diabetes improvement after bariatric surgery. It also tests if starting non-invasive transcutaneous vagal nerve stimulation (tVNS) therapy 30 days post-surgery can further improve cognitive functions. The cost of the surgery itself isn't covered by the study.

Participant Groups

Group I: tVNS + complete vagotomy Experimental Treatment 2 Interventions

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

Group II: tVNS + anterior vagotomy Experimental Treatment 2 Interventions

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.

Group III: Sham + complete vagotomy Placebo Group 1 Intervention

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.

Group IV: Sham + anterior vagotomy Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

In a study of 24 children undergoing intermittent vagal nerve stimulation over a total of 61 patient years, 15 adverse events were reported, with 13 likely related to the device, indicating a need for careful monitoring during treatment.

Despite the occurrence of adverse events, vagal nerve stimulation was generally well tolerated, and unlike standard drug therapies, these events did not typically require stopping the treatment, although they sometimes led to unexpected surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in children receiving intermittent left vagal nerve stimulation. Murphy, JV., Hornig, GW., Schallert, GS., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral effects of vagotomy in humans. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Regeneration may mediate the sparing of VMH obesity observed with prior vagotomy. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Truncal vagotomy in morbid obesity. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Vagotomy as a treatment for morbid obesity. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation does not lead to significant changes in body weight in patients with epilepsy. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events in children receiving intermittent left vagal nerve stimulation. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study. [2018]