Vagal Nerve Stimulation for Gastroparesis
(ABVN2 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Disqualifiers: Pregnancy, Prisoners, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to find out if we can gain access to the vagus nerve which is largely an internal nerve that controls stomach function. We hope to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If we can do this then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the treatment Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS) for gastroparesis?
Research shows that TaVNS can help normalize stomach rhythm issues in healthy individuals, suggesting it might be beneficial for gastroparesis, a condition with similar symptoms.
12345Is transcutaneous auricular vagus nerve stimulation (taVNS) safe for humans?
Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe for humans, with mild and temporary side effects like ear pain, headache, and tingling. There is no evidence of severe adverse effects directly caused by taVNS.
34678How is the treatment TaVNS different from other treatments for gastroparesis?
TaVNS is unique because it uses low-intensity electrical currents applied to the ear to stimulate the vagus nerve, which can help regulate stomach rhythms. Unlike traditional treatments that might involve medication or surgery, TaVNS is non-invasive and can be administered several times a day without the need for drugs.
45789Eligibility Criteria
This trial is for individuals with gastroparesis, a condition that affects stomach emptying. It's open to those who haven't had a gastric stimulator placed and are interested in non-invasive nerve stimulation therapy.Inclusion Criteria
I am healthy with no stomach issues unrelated to COVID-19.
I am between 18 and 80 years old.
I am willing to have electrodes placed on my ear.
+8 more
Exclusion Criteria
I am unable to give my consent.
Pregnant females
Prisoners
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Stimulation
Subjects undergo transcutaneous stimulation of the auricular branch of the vagus nerve and blood draws before and after stimulation
3 hours
1 visit (in-person)
Vagal Maneuvers
Subjects undergo vagal maneuvers using either regular EKG electrodes or MEA electrodes
3 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after stimulation and maneuvers
4 weeks
Participant Groups
The study tests the effects of ABVN (auricular branch of vagal nerve) stimulation on nerve action potentials and gastric hormones using devices like GES, TaVNS, PENFS, and a wrist-worn Cardio Watch.
2Treatment groups
Experimental Treatment
Group I: Healthy SubjectsExperimental Treatment2 Interventions
Subjects who have no gastric symptoms or conditions
Group II: Gastroparesis SubjectsExperimental Treatment2 Interventions
Subjects with a confirmed diagnosis of gastroparesis.
Transcutaneous Auricular Vagal Nerve Stimulation (TaVNS) is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as TaVNS for:
- Epilepsy
- Depression
- Pain
- Migraine
🇺🇸 Approved in United States as TaVNS for:
- Epilepsy
- Depression
- Chronic pain syndromes
- Migraine
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana UniversityIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
References
Toward Diverse or Standardized: A Systematic Review Identifying Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve in Nomenclature. [2023]After 20 years of development, there is confusion in the nomenclature of transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN). We performed a systematic review of transcutaneous stimulation of ABVN in nomenclature.
Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. [2020]Electrical stimulation of the auricular branch of the vagus nerve (ABVN) via transcutaneous auricular vagus nerve stimulation (taVNS) may influence afferent vagal networks. There have been 5 prior taVNS/fMRI studies, with inconsistent findings due to variability in stimulation targets and parameters.
Optimizing the modulation paradigm of transcutaneous auricular vagus nerve stimulation in patients with disorders of consciousness: A prospective exploratory pilot study protocol. [2023]Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique. Several studies have reported the effectiveness of taVNS in patients with disorders of consciousness (DOC); however, differences in the modulation paradigm have led to inconsistent treatment outcomes.
Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. [2023]Transcutaneous auricular vagus nerve stimulation (TaVNS) is a supplementary treatment for gastric symptoms resulting from dysrhythmias. The main objective of this study was to quantify the effects of 10, 40, and 80 Hz TaVNS and sham in healthy individuals in response to a 5-minute water-load (WL5) test.
High-resolution computational modeling of the current flow in the outer ear during transcutaneous auricular Vagus Nerve Stimulation (taVNS). [2023]Transcutaneous auricular Vagus Nerve Stimulation (taVNS) applies low-intensity electrical current to the ear with the intention of activating the auricular branch of the Vagus nerve. The sensitivity and selectivity of stimulation applied to the ear depends on current flow pattern produced by a given electrode montage (size and placement).
Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]Transcutaneous auricular vagus nerve stimulation (taVNS) has been investigated as a novel neuromodulation tool. Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet been investigated. This systematic review and meta-analysis on taVNS aimed to (1) systematically analyze study characteristics and AE assessment, (2) characterize and analyze possible AEs and their incidence, (3) search for predictable risk factors, (4) analyze the severity of AE, and (5) suggest an evidence-based taVNS adverse events questionnaire for safety monitoring. The articles searched were published through April 7, 2022, in Medline, Embase, Web of Science, Cochrane, and Lilacs databases. In general, we evaluated 177 studies that assessed 6322 subjects. From these, 55.37% of studies did not mention the presence or absence of any AEs; only 24.86% of the studies described that at least one adverse event occurred. In the 35 studies reporting the number of subjects with at least one adverse event, a meta-analytic approach to calculate the risk differences of developing an adverse event between active taVNS and controls was used. The meta-analytic overall adverse events incidence rate was calculated for the total number of adverse events reported on a 100,000 person-minutes-days scale. There were no differences in risk of developing an adverse event between active taVNS and controls. The incidence of AE, in general, was 12.84/100,000 person-minutes-days of stimulation, and the most frequently reported were ear pain, headache, and tingling. Almost half of the studies did not report the presence or absence of any AEs. We attribute this to the absence of AE in those studies. There was no causal relationship between taVNS and severe adverse events. This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical intervention.
The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. [2023]Transcutaneous auricular vagus nerve stimulation (taVNS) is used for treating depression but the efficacy and safety have not been well assessed. This study was conducted to evaluate the efficacy and safety of taVNS in depression.
[Clinical Application of Transcutaneous Auricular Vagus Nerve Stimulation]. [2022]Transcutaneous auricular vagus nerve stimulation (taVNS) refers to stimulation of the vagus nerve through the skin of the left cymba conchae and is a unique strategy that is investigated as a useful therapeutic approach for a variety of conditions including epilepsy, depression, cardiac diseases, tinnitus, and migraine. A randomized double-blind clinical trial was performed in patients with drug-resistant epilepsy. Although several pilot studies were performed before this trial and showed that taVNS was safe, well tolerated, and feasible for long-term treatment, no statistically significant difference was observed between the high- and low-stimulation groups, and further studies are warranted to gain a deeper understanding of this subject. A tingling sensation or pain at the site of stimulation is the most common adverse effect associated with taVNS. Therefore, intermittent stimulation, ranging from 30 minutes to several hours, is provided during each session several times a day. Currently, taVNS is not approved for insurance coverage by the Japan Ministry of Health, Labour, and Welfare. Further studies and investigations are necessary in the near future.
Short trains of transcutaneous auricular vagus nerve stimulation (taVNS) have parameter-specific effects on heart rate. [2020]Optimal parameters of transcutaneous auricular vagus nerve stimulation (taVNS) are still undetermined. Given the vagus nerve's role in regulating heart rate (HR), it is important to determine safety and HR effects of various taVNS parameters.