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Vagal Nerve Stimulation for Gastric Motor Functions

N/A

Waitlist Available

Led By Michael Camilleri

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must be at least 18 years old

Disabling seizures (those with significant negative impact on the patient's life)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10-30 minutes after meal ingestion

Awards & highlights

Study Summary

This trial tests if a nerve stimulation therapy can help the stomach empty food faster and better accommodate food.

Who is the study for?

This trial is for adults over 18 with drug-resistant epilepsy and disabling seizures, who are not candidates for resective surgery. Participants must be medically stable apart from epilepsy, able to attend study visits, and use birth control if applicable. Excluded are those recently in other trials or hospitalized for psychiatric conditions, on certain medications like anticoagulants or immunosuppressants, weigh over 350 pounds, can't eat eggs (used in tests), have substance abuse history or vocal cord paralysis.Check my eligibility

What is being tested?

The trial studies the effect of vagal nerve stimulation (VNS) on how the stomach functions after eating a meal. Specifically, it looks at whether activating VNS changes the stomach's ability to hold food and pass it into the intestines. Patients' responses before and three months after VNS activation will be compared using imaging techniques.See study design

What are the potential side effects?

While specific side effects of vagal nerve stimulant aren't detailed here, common ones may include voice changes due to nerve stimulation near the vocal cords, coughing or throat pain during device activation; tingling sensation in skin where device is placed; possible change in heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I experience seizures that significantly affect my daily life.

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I still have seizures despite trying at least 2 different seizure medications.

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Aside from epilepsy, I am in stable health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gastric accommodation

Gastric emptying T1/2

Secondary outcome measures

Fasting proximal gastric volume

Fasting whole volume volume

Gastric emptying 25%

+5 more

Side effects data

From 2016 Phase 3 trial • 230 Patients • NCT01109849

63%

loss of appetite

49%

irritability

48%

anxiety

42%

skin picking

41%

trouble sleeping

35%

depressed mood

32%

stomachache

29%

headache

26%

dull, listless

20%

socially withdrawn

18%

motor/verbal tics

15%

buccal movements

abdominal pain

appendicitis

self injurious behavior

shortness of breath

100%

80%

60%

40%

20%

Study treatment Arm

Dose Optimzed

Behavior Therapy

ER Stimulant

Trial Design

1Treatment groups

Experimental Treatment

Group I: vagal nerve stimulantExperimental Treatment1 Intervention

The aim is to measure gastric emptying and gastric accommodation in response to a caloric meal before and 3 months after activation of VNS. Therefore, prior to surgery, subjects will undergo combined gastric emptying/accommodation test. Subsequently, participants will undergo a second identical study approximately 3 months after insertion of the VNS.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,768 Total Patients Enrolled

22 Trials studying Epilepsy

1,176 Patients Enrolled for Epilepsy

University of MinnesotaOTHER

1,377 Previous Clinical Trials

1,588,280 Total Patients Enrolled

12 Trials studying Epilepsy

515 Patients Enrolled for Epilepsy

Michael CamilleriPrincipal InvestigatorMayo Clinic

4 Previous Clinical Trials

101 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aim of this clinical experiment?

"This 4 hour gastric emptying test seeks to assess Gastric accommodation as its primary objective. Secondary assessments include the time taken to empty 25% of the stomach, and the percentage emptied from the entire stomach at both 2 hours and 4 hours."

Answered by AI

Can individuals still submit an application to participate in this research?

"Details on clinicaltrials.gov suggest that this medical trial is no longer actively enrolling participants; the study was first posted in September 1st, 2023 and last modified on September 14th of the same year. However, there are currently 1465 other trials that remain open to potential patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Vagal Nerve Stimulation on Gastric Motor Functions

Michael Camilleri, MD 2024. "Effect of Vagal Nerve Stimulation on Gastric Motor Functions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06038929.

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