DepressionNCT06038929
Effect of Vagal Nerve Stimulation on Gastric Motor Functions
A study testing Vagal nerve stimulant in people with Depression and Epilepsy, run by Mayo Clinic at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Epilepsy
- What is being tested?
- Vagal nerve stimulant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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).
- Participant has been hospitalized for a psychiatric condition within the preceding 6 months or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis).
- Participant has experienced unprovoked status epilepticus in the preceding year.
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- Participant is not able or willing to use their dominant arm, or either upper arm circumference is greater than 50 cm.
- Any other clinical reasons deemed by the investigators of the study for which the participant would not be an appropriate candidate for the study, such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension (OH), postural orthostatic tachycardia syndrome (POTS), uncontrolled obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes or pregnancy
- Participant with vocal cord paralysis
- Participant cannot speak and read English.
- Participant is pregnant.
- Prohibited Therapy During Study Period: We will exclude patients on immunosuppressants, beta blockers, anticholinergics, and clonidine. Consultation with primary providers and amending some of these therapies may be allowed only if clinically indicated. In that case, participants will have to be stable on their new medication for at least one month prior to implant.
- A body weight of over 350 pounds or 159 kilograms due to equipment limitations used in the measurements of gastric accommodation and emptying.
- An inability to eat eggs whether due to an allergy, intolerance, or strong dislike. The gastric emptying test meal contains eggs that are labeled with radioisotope. Other food substitutions for the toast, butter and milk may be made only if prior approval is given by Dr. Camilleri.
- Any other factor that may impact participant safety or compliance as per PI.
- Since participants with pVNS will be recruited from the CSP study at U Minnesota, it is important to specify the inclusion and exclusion criteria for participants with drug-resistant epilepsy or drug-resistant depression who entered the CSP study:
- Inclusion Criteria for Participants With Major Depressive Disorder That Have a Previously Implanted VNS Device
- 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 must be enrolled in an active health insurance plan that will cover the costs associated with standard health care services and injuries.
- Participant must have been previously implanted with a VNS device for the clinical indication of Major Depressive Disorder (MDD).
- Participant must have a score on the baseline administration of the Montgomery-Åsberg Depression Rating Scale (MADRS) of ≥ 22.
- Participant must be able and willing to complete the evaluations and procedures described in the study protocol.
- Participant must be able and willing to follow the stipulations regarding concomitant medications and excluded medications described in section 5.3 of the study protocol.
- Participant that is of childbearing potential must be adequately protected from conception or willing to use an acceptable method of birth control over the entire study duration (acceptable birth control includes abstinence, barrier methods, hormonal methods, sterilization and fertility awareness).
- Exclusion Criteria for Participants With Major Depressive Disorder That Have a Previously Implanted VNS Device
- Participant has a prior implantable stimulation device, other than a VNS device for the clinical indication of Major Depressive Disorder (MDD).
- Participant currently uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy.
- Participant is judged by the investigator to be acutely suicidal (e.g. has made specific plans or preparations to commit suicide or as indicated by the Sheehan Suicidality Tracking Scale) within the last 30 days prior to study enrollment.
- Participant has made a suicide attempt within the previous 6 months from study enrollment.
- Participant has a history of one or more schizophrenia-spectrum or other psychotic disorders including schizophrenia, schizoaffective disorder, delusional disorder, or a current or lifetime major depressive episode that includes psychotic features (commonly referred to as psychotic depression) according to the MINI criteria.
- Participant has a history of significant borderline or severe personality disorder as determined by clinical judgment.
- Participant has an active primary diagnosis of obsessive-compulsive, eating, or post-traumatic stress disorder based on the MINI criteria.
- Participant has a diagnosis of Substance Use Disorder as defined by DSM-5 without sustained remission of 12 months or longer.
- Participant has a presence of any type of dementia, major neurocognitive disorder, or cognitive or psychiatric deficit as determined by clinical judgment.
- Participant has a history of rapid cycling bipolar disorder I or II.
- Participant currently receives treatment with another investigational device or investigational drug other than the REVEAL study (or a REVEAL ancillary project or sub-study) or has participated in another drug or device trial within the preceding 30 days before enrollment.
- Participant is not able or willing to use their dominant arm, or either upper arm circumference is greater than 50 cm.
- Participant does not speak English.
- Participant is pregnant.
- Any other clinical reasons deemed by the investigators of the study for which the participant would not be an appropriate candidate for the study, such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension (OH), postural orthostatic tachycardia syndrome (POTS), uncontrolled obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes.
- Inclusion Criteria for Participants With Drug Resistant Epilepsy That Have a Previously Implanted VNS Device
- 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 must be enrolled in an active health insurance plan that will cover the costs associated with standard health care services and injuries.
- Participant must have been previously implanted with a VNS device for the clinical indication of drug resistant epilepsy.
- Participant has not had demonstrable benefit from the implanted VNS device in terms of epilepsy (seizure frequency or seizure severity) or related epilepsy comorbidities (mood, cognition, quality of life), with no definite improvement or suboptimal improvement in seizure control.
- Apart from epilepsy, the participant should be medically and neurologically stable.
- Participant must be able and willing to complete the evaluations and procedures described in the study protocol.
- Participant must be able and willing to follow the stipulations regarding concomitant medications and excluded medications described in section 5.3 of the study protocol.
- Participant that is of childbearing potential must be adequately protected from conception or willing to use an acceptable method of birth control over the entire study duration (acceptable birth control includes abstinence, barrier methods, hormonal methods, sterilization and fertility awareness).
- Exclusion Criteria for Participants With Drug Resistant Epilepsy That Have a Previously Implanted VNS Device
- Participant has demonstrable benefit from implanted VNS device in terms of epilepsy (seizure frequency or seizure severity) or epilepsy comorbidity (mood, cognition, or quality of life), with seizure freedom or clinical benefit.
- Participant has a prior implantable stimulation device, other than a VNS device for the clinical indication of refractory focal Epilepsy.
- Participant currently uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy.
- Participant has been hospitalized for a psychiatric condition within the preceding 6 months or has had a history of psychosis within the preceding two years (excluding postictal psychosis).
- Participant has experienced unprovoked status epilepticus in the preceding year.
- Participant has a diagnosis of Substance Use Disorder as defined by DSM-5 without sustained remission of 12 months or longer.
- Participant currently receives treatment with another investigational device or investigational drug other than the REVEAL study (or a REVEAL ancillary project or sub-study) or has participated in another drug or device trial within the preceding 30 days before enrollment.
- Participant is not able or willing to use their dominant arm, or either upper arm circumference is greater than 50 cm.
- Participant does not speak English.
- Participant is pregnant.
- Any other clinical reasons deemed by the investigators of the study for which the participant would not be an appropriate candidate for the study, such as peripheral vascular disease, Raynaud's phenomenon, orthostatic hypotension (OH), postural orthostatic tachycardia syndrome (POTS), uncontrolled obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Kathryn Vera, PhD, 612-625-5018, giero002@umn.edu
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Paula Carlson, BS, 507-284-2511, carlson.paula@mayo.edu
John Osborn, PhD
About this study
Official title: REVEAL - Research Evaluating Vagal Excitation and Anatomical Linkages Gastric Emptying Ancillary Project: Effect of Vagal Nerve Stimulation on Gastric Motor Functions
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.
Read the detailed description
Objectives To compare simultaneous assessment of gastric emptying and gastric accommodation in response to the same caloric meal in patients who have undergone activation of left cervical Vagal Nerve Stimulation.
Design and Outcomes Single cohort study in 12 Vagus Nerve Stimulant-implanted subjects with drug-resistant depression, aged 18 years or older who were consented for the main VESPA REVEAL Common Study Protocol.
There is only 1 visit needed, with an average time commitment of 4.5 hours. Participants will have completed their planned VESPA REVEAL study visits Interventions and Duration In this single cohort study in 12 Vagus Nerve Stimulant-implanted subjects, each participant will undergo combined gastric emptying/accommodation test after completing the Visits required in CSP
Sample Size and Population
Sample size assessment. This will be based on results of the primary endpoints in our Mayo Clinic lab. We expect 80% power, α=0.05, assuming unpaired t-test analysis with n=12 in patients receiving VNS compared to the healthy control data (n=300 for both gastric emptying and gastric volume . Demonstrable differences (Table 1) will be based on the variation (SD) observed from our Mayo Clinic prior studies.
Table 1A. Effect size demonstrable for primary endpoints of interest, based on 80% power at α=0.05 (for n=12 with p-VNS): PRIMARY ANALYSIS
Response Meal SD Effect size detectable [absolute (% of mean)]
Fasting gastric volume, mL 273 57 471mL (17.3%)
Postmeal gastric volume, mL 848 111 92mL (10.8%)
GE of solids T1/2, min 122 29.8 24.7 min (20.2%)
In addition, these effect sizes are feasible in response to vagal intervention, whether it turns out to be stimulatory or inhibitory, and a 26-minute difference in GE T1/2 is clinically significant, as documented in a published meta-regression from our research team.
Human subjects. Participants will be recruited primarily from the University of Minnesota (90-minute drive away). With only limited added burden on participants, who will previously have undergone placement of vagal nerve stimulator. There is only 1 total visits needed, with an average time commitment of 4.5 hours.
The patients will have undergone placement of the VNS for clinical indications.
The objective of the study is to evaluate the effects of this treatment on gastric functions, rather than any therapeutic intent, or the development of a new indication to be submitted to regulatory agencies for an additional therapeutic indication. Therefore, it is perceived that an application for an investigational device exemption (IDE) is not required.
- Conditions
- Depression, Epilepsy
- Being tested
- Vagal nerve stimulant
- Medical subject headings
- Depression, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal nerve stimulantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| vagal nerve stimulant | Experimental | The aim is to measure gastric emptying and gastric accommodation in response to a caloric meal in participants who have received insertion of the VNS for the treatment of medication - resistant depression. Receives: Device: Vagal nerve stimulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying T1/2
time to empty 50% of the whole stomach contents
Measured: during 4 hour gastric emptying test
Gastric accommodation
gastric delta volume (postprandial minus fasting) for the whole stomach
Measured: during first 1 hour of gastric emptying test
Secondary outcomes (8)
Gastric emptying lag time
time to empty 10% of the whole stomach
Measured: 1 day (during gastric emptying test)
Gastric emptying 25%
time to empty 25% of the whole stomach
Measured: 1 day (during gastric emptying test)
Gastric emptying at 2 hours
% emptied from the whole stomach at 2h
Measured: 2 hours (during gastric emptying test)
Gastric emptying at 4 hours
% emptied from the whole stomach at 4h
Measured: 4 hours (during gastric emptying test)
Fasting whole volume volume
volume of whole stomach before ingestion of meal
Measured: baseline
Fasting proximal gastric volume
volume of proximal half of stomach before ingestion of meal
Measured: baseline
Postprandial whole gastric volume
volume of whole stomach 10-30 minutes after ingestion of meal
Measured: 10-30 minutes after meal ingestion
Postprandial proximal gastric volume
volume of proximal half of stomach 10-30 minutes after ingestion of meal
Measured: 10-30 minutes after meal ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Sep 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single cohort, open label study in 16 Vagus Nerve Stimulant-implanted subjects with drug-resistant epilepsy with seizures or depression, aged 18 years or older
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038929
- Sponsor's protocol ID
- 23-006558
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVEAL - Research Evaluating Vagal Excitation and Anatomical Linkages Gastric Emptying Ancillary Project: Effect of Vagal Nerve Stimulation on Gastric Motor Functions
- ClinicalTrials.gov ID
- NCT06038929
- Acronym / sponsor ID
- 23-006558
- Conditions
- Depression, Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives To compare simultaneous assessment of gastric emptying and gastric accommodation in response to the same caloric meal in patients who have undergone activation of left cervical Vagal Nerve Stimulation.
Design and Outcomes Single cohort study in 12 Vagus Nerve Stimulant-implanted subjects with drug-resistant depression, aged 18 years or older who were consented for the main VESPA REVEAL Common Study Protocol.
There is only 1 visit needed, with an average time commitment of 4.5 hours. Participants will have completed their planned VESPA REVEAL study visits Interventions and Duration In this single cohort study in 12 Vagus Nerve Stimulant-implanted subjects, each participant will undergo combined gastric emptying/accommodation test after completing the Visits required in CSP
Sample Size and Population
Sample size assessment. This will be based on results of the primary endpoints in our Mayo Clinic lab. We expect 80% power, α=0.05, assuming unpaired t-test analysis with n=12 in patients receiving VNS compared to the healthy control data (n=300 for both gastric emptying and gastric volume . Demonstrable differences (Table 1) will be based on the variation (SD) observed from our Mayo Clinic prior studies.
Table 1A. Effect size demonstrable for primary endpoints of interest, based on 80% power at α=0.05 (for n=12 with p-VNS): PRIMARY ANALYSIS
Response Meal SD Effect size detectable [absolute (% of mean)]
Fasting gastric volume, mL 273 57 471mL (17.3%)
Postmeal gastric volume, mL 848 111 92mL (10.8%)
GE of solids T1/2, min 122 29.8 24.7 min (20.2%)
In addition, these effect sizes are feasible in response to vagal intervention, whether it turns out to be stimulatory or inhibitory, and a 26-minute difference in GE T1/2 is clinically significant, as documented in a published meta-regression from our research team.
Human subjects. Participants will be recruited primarily from the University of Minnesota (90-minute drive away). With only limited added burden on participants, who will previously have undergone placement of vagal nerve stimulator. There is only 1 total visits needed, with an average time commitment of 4.5 hours.
The patients will have undergone placement of the VNS for clinical indications.
The objective of the study is to evaluate the effects of this treatment on gastric functions, rather than any therapeutic intent, or the development of a new indication to be submitted to regulatory agencies for an additional therapeutic indication. Therefore, it is perceived that an application for an investigational device exemption (IDE) is not required.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single cohort, open label study in 16 Vagus Nerve Stimulant-implanted subjects with drug-resistant epilepsy with seizures or depression, aged 18 years or older
| Arm | Type | Receives |
|---|---|---|
| vagal nerve stimulant | Experimental | Device: Vagal nerve stimulantThe aim is to measure gastric emptying and gastric accommodation in response to a caloric meal in participants who have received insertion of the VNS for the treatment of medication - resistant depression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (63 listed)
- 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).
- Participant has been hospitalized for a psychiatric condition within the preceding 6 months or has had a history of psychosis within the preceding two years (excluding post-ictal psychosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagal nerve stimulantVagus 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. | Device | vagal nerve stimulant |
Primary outcome
Gastric emptying T1/2
Time frame: during 4 hour gastric emptying test
time to empty 50% of the whole stomach contents
Gastric accommodation
Time frame: during first 1 hour of gastric emptying test
gastric delta volume (postprandial minus fasting) for the whole stomach
8 secondary outcomes
Gastric emptying lag time
Time frame: 1 day (during gastric emptying test)
Gastric emptying 25%
Time frame: 1 day (during gastric emptying test)
Gastric emptying at 2 hours
Time frame: 2 hours (during gastric emptying test)
Gastric emptying at 4 hours
Time frame: 4 hours (during gastric emptying test)
Fasting whole volume volume
Time frame: baseline
Fasting proximal gastric volume
Time frame: baseline
Postprandial whole gastric volume
Time frame: 10-30 minutes after meal ingestion
Postprandial proximal gastric volume
Time frame: 10-30 minutes after meal ingestion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Camilleri principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal nerve stimulant in people with Depression and Epilepsy, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 63 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying T1/2 (time frame: during 4 hour gastric emptying test). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.