Auricular Neurostimulation for Cyclic Vomiting Syndrome

Medical College of Wisconsin

Status: Completed

Conditions: Cyclic Vomiting Syndrome; Abdominal Migraine

Treatments: Device: Percutaneous neurostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03434652

1102505-4

Details and patient eligibility

About

This study evaluates the efficacy of auricular neurostimulation via an non-invasive percutaneous electrical nerve field stimulator in children and adults with cyclic vomiting syndrome.

Full description

Cyclic vomiting syndrome (CVS) is an difficult to treat and debilitating functional gastrointestinal disorder presenting with episodes of severe nausea and vomiting. Majority of children and adults with CVS have concurrent severe abdominal pain and migraine-features, rendering them incapacitated during the vomiting cycle.

The vagus nerve carries signals of nausea, vomiting and pain between the brain and the gastrointestinal tract and is part of the autonomic nervous system. The autonomic nervous system appears to be in imbalance in patients with CVS during a vomiting cycle. By stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms and quality of life in both children and adults with CVS.

Subjects in Acute treatment arm will be randomized to receive active vs sham (non-active) neurostimulation therapy for 5 days at the onset of a CVS cycle (1st illness period). They will then cross over to the other group (active vs sham) at the onset of the next CVS cycle (2nd illness period). Subjects in a separate Chronic (Prophylactic) treatment arm receive 6 consecutive weeks of active neurostimulation therapy (5 days/week). Pain, nausea, vomiting, anxiety, quality of life, potential side effects and overall symptom improvement will be monitored before and after therapy.

Enrollment: 47 patients

Sex: All

Ages: 8 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meeting Rome IV Pediatric or Adult criteria for Cyclic Vomiting Syndrome (CVS)
• Concurrent abdominal pain with CVS cycle
• English-speaking
• Lack of other explanation for symptoms
• Either predictable, 'calendar-timed' episodes or prodromal symptoms for 12-24 hours that are predictive of episodes onset

Exclusion criteria

• Medically complex and/or suffering from medical condition that may explain symptoms
• Taking a medication that may explain symptoms
• Significant developmental delays
• Patients treated with a new drug affecting the central nervous system within one week of enrollment
• Infection or severe dermatological condition of ear
• Stable vital signs
• No currently implanted electrical device
• For adults (and adolescents as applicable): pregnancy, severe cardiopulmonary disease, concurrent chronic marijuana use (>2 times/month over past 6 months prior to enrollment)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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47 participants in 2 patient groups

Acute therapy: active vs sham percutaneous neurostimulation

Sham Comparator group

Description:

Subject randomized to 5 days of active or sham neurostimulation therapy during the first illness cycle. With the second illness cycle, each subject will then cross over to the other therapy (active or sham).

Treatment:

Device: Percutaneous neurostimulation

Chronic therapy: active (open-label) percutaneous neurostimulation

Experimental group

Description:

Each subject receives 6 consecutive weeks of active (open-label) neurostimulation therapy.

Treatment:

Device: Percutaneous neurostimulation