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Vagal Nerve Stimulation for Gastric Motor Functions

N/A

Recruiting

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)

Must not have

Subject currently uses or during the study is expected to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy

Subject has been hospitalized for a psychiatric condition within the preceding two years or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10-30 minutes after meal ingestion

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use or will use therapies like short-wave or ultrasound for treatment.

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I have not been hospitalized for a psychiatric condition or had psychosis in the last two years.

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I cannot stop taking my blood thinners for surgery as advised by my doctor.

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I have vocal cord paralysis.

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I am not taking immunosuppressants, beta blockers, anticholinergics, or clonidine.

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I weigh less than 350 pounds or 159 kilograms.

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I have had a severe seizure without a clear cause in the last year.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gastric accommodation

Gastric emptying T1/2

Secondary study objectives

Fasting proximal gastric volume

Fasting whole volume volume

Gastric emptying 25%

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 11Eligibility criteria met