Auricular Neurostimulation for Cyclic Vomiting Syndrome

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2021-03-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cyclic Vomiting Syndrome Abdominal Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Arm 1 (Acute treatment): Each subject randomized to active vs sham therapy during 1st illness cycle after enrollment, then cross over to the other (active vs sham) during the 2nd illness cycle.

Arm 2 (Chronic treatment): Active, chronic (prophylactic) therapy (open label) x 6 consecutive weeks of intervention.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind, cross over study for Arm 1 (Acute treatment) only Arm 2: open-label

Study Groups

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Acute therapy: active vs sham percutaneous neurostimulation

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).

Group Type SHAM_COMPARATOR

Percutaneous neurostimulation

Intervention Type DEVICE

Auricular percutaneous neurostimulation

Chronic therapy: active (open-label) percutaneous neurostimulation

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

Group Type EXPERIMENTAL

Percutaneous neurostimulation

Intervention Type DEVICE

Auricular percutaneous neurostimulation

Interventions

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Percutaneous neurostimulation

Auricular percutaneous neurostimulation

Intervention Type DEVICE

Other Intervention Names

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Neuro-Stim System (NSS)-2 BRIDGE

Eligibility Criteria

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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)

Minimum Eligible Age

8 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No