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Abortive Effect of an Ear Insufflator on Migraine

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ClinicalTrials.gov Identifier: NCT02614378
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : December 14, 2016
Sponsor:
Information provided by (Responsible Party):
Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies

Tracking Information
First Submitted Date  ICMJE November 21, 2015
First Posted Date  ICMJE November 25, 2015
Last Update Posted Date December 14, 2016
Study Start Date  ICMJE November 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
  • Changes in Symptoms severity scale at 2h [ Time Frame: pre-treatment, 2h 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 24h [ Time Frame: pre-treatment, 24h 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
  • Changes in blood pressure [ Time Frame: pre-treatment, immediately post-treatment ]
    Blood pressure will be measured. Changes in blood pressure will be assessed between pre and immediately post treatment
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Abortive Effect of an Ear Insufflator on Migraine
Official Title  ICMJE Abortive Effect of an Ear Insufflator on Migraine
Brief Summary Evaluate the effectiveness of air insufflation in aborting (stopping) an acute episode of migraine and compare it with a placebo effect of using the same procedure but without active insufflation. The insufflation will be used when the subject is experiencing an acute episode of migraine to determine its ability to reduce, if not to completely eliminate the migraine symptoms. Subjects receiving the placebo treatment will be offered the active treatment during the subsequent episode of migraine.
Detailed Description

Each patient will be asked (using a questionnaire) to describe the nature of their presenting symptoms including distribution pattern, symmetry, laterality, severity and associated symptoms. Severity of migraine/headache will be recorded. The patient's description of their symptoms will be used to guide the treatment process in terms of treatment time and side (i.e. left or right ear). A tubular soft silicone ear-plug will be inserted into the patient's ear on the side of greatest reported severity. In the absence of clear laterality with respect to severity, the side associated with the greatest surface area of involvement will be selected (e.g., the patient has a bilateral headache but on the left, it is perceived as retro-orbital whereas on the right it is retro-orbital and temporal, therefore the right side will be selected), In the absence of lateralizing features, the initial treatment side will be randomly selected. Then the air insufflation will start. The patient will be encouraged to relax during the process and the extent of the insufflation will be maintained a level that is comfortable for the patient. The patient will be asked to report any sense of aggravation of their symptoms, which would prompt the examiner to suspend the treatment. The patient will not know if the treatment received is the active or the placebo one.

Following insufflation, the ear plug will be removed and the patient will be asked to rate the severity of their symptoms and describe any changes in characteristics. A significant reduction in pain level will be considered an indication that the treatment is appropriate for that patient and the treatment will then continue on the ipsilateral side. If the patients will describe resolution of their symptoms in a hemi-distribution of the head ("the symptoms are gone from this side of my head but they're still left on the other side"), the treatment process will be repeated on the contralateral side until resolution (or maximal reduction in symptoms) will be achieved. Treatment session in this study will last 20 minutes.

There will be a followup at 2h and 24h post treatment to monitor the status of the patient and they will all be invited back for a second treatmentduring the subsequent episode of migraine.

Vitals (blood pressure, heart rate, pulse oxygenation and temperature) will also be monitored to see if there are any changes before and immediately after treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Procedure: air insufflation
    modulated air insufflation of the ear canal
  • Procedure: placebo
    no air will be introduced in the ear canal
Study Arms  ICMJE
  • Active Comparator: Subject receiving treatment
    participant receiving air insufflation
    Intervention: Procedure: air insufflation
  • Placebo Comparator: Subject receiving placebo
    participant not receiving air insufflation
    Intervention: Procedure: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2016)
58
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2015)
25
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant/nursing women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02614378
Other Study ID Numbers  ICMJE CI-IRB-20151104001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Frederick Carrick, PhD, FACCN, Carrick Institute for Graduate Studies
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Carrick Institute for Graduate Studies
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frederick R Carrick, PhD Carrick Institute for Graduate Studies
PRS Account Carrick Institute for Graduate Studies
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP