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Feasibility of Using a Mobile Device Controlled Micro-pressure Pulse Insufflator for Acute Migraine Relief

NCT03263897 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2022-07-21

No results posted yet for this study

Summary

Evaluate the feasibility of using a mobile interface to control the insufflator device administering treatment for aborting (stopping) an acute episode of migraine. The patient, under clinical supervision, will use the mobile interface to "self administer" the treatment when experiencing an acute episode of migraine. The supervising clinician will monitor the patient and the device to make sure that no harm could come to the patient and will be ready to intervene if any adverse effects were suspected to or in the process of happening.

Conditions

Interventions

DEVICE

insufflation

mobile interface driven insufflation of the ear canal

DEVICE

placebo insufflation

mobile interface driven placebo insufflation of the ear canal

Sponsors & Collaborators

  • Caps Research Network

    lead OTHER

Principal Investigators

  • David M George, DC · GBS Ventures

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-21
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03263897 on ClinicalTrials.gov