We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified August 2017 by Caps Research Network
Sponsor:
ClinicalTrials.gov Identifier:
NCT03263897
First Posted: August 28, 2017
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Caps Research Network
  Purpose
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.

Condition Intervention
Migraine Device: insufflation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Using a Mobile Device Controlled Micro-pressure Pulse Insufflator for Acute Migraine Relief

Resource links provided by NLM:


Further study details as provided by Caps Research Network:

Primary Outcome Measures:
  • Changes in Symptoms severity scale [ Time Frame: pre-treatment, immediately post-treatment ]
    Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and immediately post treatment


Secondary Outcome Measures:
  • Changes in Symptoms severity scale at 2 hours [ Time Frame: pre-treatment, 2 hours post-treatment ]
    Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and 2h post treatment

  • Changes in Symptoms severity scale at 24 hours [ Time Frame: pre-treatment, 24 hours post-treatment ]
    Subjects will grade the severity of their symptoms on a scale from 0 to 10. Changes in the symptoms severity scale will be assessed between pre and 24h post treatment


Estimated Enrollment: 50
Actual Study Start Date: August 21, 2017
Estimated Study Completion Date: August 31, 2018
Estimated Primary Completion Date: February 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients
Receiving insufflation during an acute episode of migraine
Device: insufflation
mobile interface driven insufflation of the ear canal

Detailed Description:

After signing the consent form and being enrolled in the study, the subject will be asked to answer an enrollment questionnaire on the general characteristics of the migraine attacks he or she is suffering. Then, the subject will be instructed to call 1-800 number to notify the clinic that they have a migraine.

Upon presentation with an acute migraine attack, the subject will be assessed by taking blood pressure, pulse, temperature, subjective pain score on a scale of 0-10 as well as subjective associated symptoms scores on the same scale. Bilateral otoscopic examination will be used to confirm intact tympanic membranes to ensure that subjects can safely receive the treatment. Also, subjects will receive bilateral hearing screening and their ability to maintain balance will be assessed.

A soft silicone ear plug will be inserted in one of the subject's ears. This plug is attached to the insufflator. The subject will control the device using a mobile app: an easy to use interface will allow the subject to provide the device all the information needed for the automatic selection of the treatment protocol most appropriate for the subject. Once selected, the treatment will last 30 minutes. The subjects heart rate, heart rate variability, and pulse oxygenation will be monitored throughout the insufflation procedure to measure physiologic response to the procedure as well as to bolster the safety of the procedure. These values will be recorded every minute (heart rate and pulse ox) on the vitals form. After 10 and 20min of treatment, the subject will be asked the corresponding pain score on a scale of 0-10. Vitals will be taken again at the end of the treatment. Bilateral hearing and ability to maintain balance will also be screened again at the end of the treatment and compared with the pre-treatment measures to see if they were affected by the treatment.

Subjective pain and symptom scores will be obtained immediately after the 30min treatment, and at the 2 hour post and 24 hour post treatment end points. Each user will receive only a single treatment, administered in the clinic setting. 2 hour and 24 hour end point assessments will be obtained telephonically.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects suffering from acute migraine episodes
  • Possibly located in the Phoenix, AZ area

Exclusion Criteria:

  • Pregnant/nursing women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263897


Contacts
Contact: David M George, DC 1-888-207-8839 DAVID@GBS.VENTURES

Locations
United States, Arizona
YRMC: Physiatry, Neurosurgery, Neurology Clinic Recruiting
Prescott, Arizona, United States, 86301
Contact: Bradley Benson, DO    928-445-4818      
Principal Investigator: David M George, DC         
Sub-Investigator: Bradley Benson, DO         
Sub-Investigator: Keith Smigiel, DC         
Sub-Investigator: Elena Oggero, PhD         
Sub-Investigator: Guido Pagnacco, PhD         
FNOR Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85254
Contact: Keith Smigiel, DC    602-485-9390      
Principal Investigator: David M George, DC         
Sub-Investigator: Bradley Benson, DO         
Sub-Investigator: Keith Smigiel, DC         
Sub-Investigator: Elena Oggero, PhD         
Sub-Investigator: Guido Pagnacco, PhD         
Sponsors and Collaborators
Caps Research Network
Investigators
Principal Investigator: David M George, DC GBS Ventures
  More Information

Responsible Party: Caps Research Network
ClinicalTrials.gov Identifier: NCT03263897     History of Changes
Other Study ID Numbers: CI-IRB-20170814001
First Submitted: August 23, 2017
First Posted: August 28, 2017
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Caps Research Network:
abortive effect
mobile interface

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases