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

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ClinicalTrials.gov Identifier: NCT03263897
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Caps Research Network

Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Device: insufflation Device: placebo insufflation Not Applicable

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 patient will be randomly assigned to two groups: an active comparator and a sham comparator. During the first session, the active group will receive the actual treatment whereas the placebo group will receive a sham treatment (using an exact replica of the device with the same software and hardware controls that delivers a simulated treatment with no actual pressure delivered - only a simulation of mechanical functions and sounds to simulate an actual treatment). During the second treatment, both groups will receive the actual treatment.

During either session, 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 (similar to the scales used in the device's interface) and on a scale from 0 to 3 (typically used in headache studies to establish the pain level) as well as subjective associated symptoms scores on the same 0-10 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. Then the subjects will be attached to a comfortable heart rate variability (HRV) monitor and asked to lie down quietly for 5 min so as to obtain a baseline HRV recording. Soft silicone ear plugs will be inserted in the subject's ears. These plugs are attached to the automated insufflator device (active or sham, depending on the group the subject is assigned to). 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, HRV, 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. The heart rate and pulse Ox values will be recorded every minute (heart rate and pulse ox) on the vitals form, the HRV will be a continuous recording for the entire duration of the treatment. 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. The subject will then be asked to lie again quietly for 5 mins as a final HRV recording is obtained for comparison against the pre-evaluation one. 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.

The second visit will follow the identical procedure with the exception that all subjects will receive an actual treatment at this stage.

Independently whether they come back for the second visit, subjects will be questioned by telephone one calendar month after their first treatment as to the number, type and intensity of migraines experienced in the period between the first treatment and the 1-month follow up phone call.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Feasibility of Using a Mobile Device Controlled Micro-pressure Pulse Insufflator for Acute Migraine Relief
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Active
Receiving insufflation during an acute episode of migraine in both visits
Device: insufflation
mobile interface driven insufflation of the ear canal

Sham Comparator: Sham
Receiving placebo insufflation during an acute episode of migraine in the first visit and receiving insufflation during an acute episode in the second visit
Device: insufflation
mobile interface driven insufflation of the ear canal

Device: placebo insufflation
mobile interface driven placebo insufflation of the ear canal




Primary Outcome Measures :
  1. Changes in Symptoms severity scale [ Time Frame: Baseline, 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

  2. Changes in pain level [ Time Frame: Baseline, immediately post-treatment ]
    Subjects will grade their pain level on a scale from 0 to 10 as well as on another scale from 0 to 3. Changes in the pain level scale will be assessed between pre and immediately post treatment


Secondary Outcome Measures :
  1. Changes in Symptoms severity scale at 2 hours [ Time Frame: Baseline, 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

  2. Changes in Symptoms severity scale at 24 hours [ Time Frame: Baseline, 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

  3. Changes in pain level at 2 hours [ Time Frame: Baseline, 2 hours post-treatment ]
    Subjects will grade their pain level on a scale from 0 to 10 as well as on another scale from 0 to 3. Changes in the pain level scale will be assessed between pre and 2h post treatment

  4. Changes in pain level at 24 hours [ Time Frame: Baseline, 24 hours post-treatment ]
    Subjects will grade their pain level on a scale from 0 to 10 as well as on another scale from 0 to 3. Changes in the pain level scale will be assessed between pre and 24h post treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older 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

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

Publications of Results:
D.M. George, G. Pagnacco, K.E. Willey, J.P. Claude, E. Oggero "SAFETY AND USABILITY FACTORS IN DEVELOPMENT OF A NOVEL, AUTOMATED TREATMENT DEVICE FOR ACUTE MIGRAINE", Biomedical Sciences Instrumentation, 2017, Vol. 53, pp 398-403.

Responsible Party: Caps Research Network
ClinicalTrials.gov Identifier: NCT03263897     History of Changes
Other Study ID Numbers: CI-IRB-20170814001
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
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