Health TrialsbyHealthPanel

Effect of Vagal Nerve Stimulation on Gastric Motor Functions

ConditionsDepressionEpilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The specific aim of this study is to compare simultaneous assessment of gastric emptying and gastric accommodation in response to a caloric meal In patients who have previously undergone activation of left cervical VNS for the treatment of medication-resistant depression. Our hypothesis is that cervical VNS increases gastric accommodation and accelerates gastric emptying compared to a bank of healthy control data.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must be at least 18 years old.

Participant must have the capacity to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Participant is diagnosed with drug Resistant Epilepsy and previously underwent implantation of VNS.

Participant is diagnosed with treatment-refractory depression and previously underwent implantation of VNS.

Disqualifiers

Participant has a prior implantable stimulation device other than a VNS device for the clinical indication of refractory focal Epilepsy or for depression.

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

Participant has a diagnosis of Substance Use Disorder as defined by DSM-5 without sustained remission of 12 months or longer.

Patient participated in another drug or device trial within the preceding 30 days (other than REVEAL studies).

Trial design

Design model

Single group

Treatments tested in this trial

  • Vagal nerve stimulant

    Device

    Vagus nerve stimulation involves using a device to stimulate the vagus nerve with electrical impulses. The implanted electrodes transmit electrical impulses travel to areas of the brain to treat conditions (intractable epilepsy, depression) and also send electrical impulses to the stomach.

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: vagal nerve stimulantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Gastric emptying T1/2

time to empty 50% of the whole stomach contents

Time frame
during 4 hour gastric emptying test
2

Gastric accommodation

gastric delta volume (postprandial minus fasting) for the whole stomach

Time frame
during first 1 hour of gastric emptying test

Secondary outcomes

1

Gastric emptying lag time

time to empty 10% of the whole stomach

Time frame
1 day (during gastric emptying test)
2

Gastric emptying 25%

time to empty 25% of the whole stomach

Time frame
1 day (during gastric emptying test)
3

Gastric emptying at 2 hours

% emptied from the whole stomach at 2h

Time frame
2 hours (during gastric emptying test)
4

Gastric emptying at 4 hours

% emptied from the whole stomach at 4h

Time frame
4 hours (during gastric emptying test)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

University of Minnesota

Collaborator

Source ClinicalTrials.gov
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