NCT03263897

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 21, 2022

Status Verified

July 1, 2022

Enrollment Period

3.4 years

First QC Date

August 23, 2017

Last Update Submit

July 18, 2022

Conditions

Migraine

Keywords

abortive effectmobile interface

Outcome Measures

Primary Outcomes (2)

  • Changes in Symptoms severity scale

    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

    Baseline, immediately post-treatment

  • Changes in pain level

    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

    Baseline, immediately post-treatment

Secondary Outcomes (4)

  • Changes in Symptoms severity scale at 2 hours

    Baseline, 2 hours post-treatment

  • Changes in Symptoms severity scale at 24 hours

    Baseline, 24 hours post-treatment

  • Changes in pain level at 2 hours

    Baseline, 2 hours post-treatment

  • Changes in pain level at 24 hours

    Baseline, 24 hours post-treatment

Study Arms (2)

Active

EXPERIMENTAL

Receiving insufflation during an acute episode of migraine in both visits

Device: insufflation

Sham

SHAM COMPARATOR

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: insufflationDevice: placebo insufflation

Interventions

insufflationDEVICE

mobile interface driven insufflation of the ear canal

ActiveSham
placebo insufflationDEVICE

mobile interface driven placebo insufflation of the ear canal

Sham

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant/nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

YRMC: Physiatry, Neurosurgery, Neurology Clinic

Prescott, Arizona, 86301, United States

Location

FNOR Clinic Scottsdale

Scottsdale, Arizona, 85254, United States

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

Insufflation

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisTherapeutics

Study Officials

  • David M George, DC

    GBS Ventures

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 28, 2017

Study Start

August 21, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 21, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)