A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache

June 15, 2019 updated by: Scion NeuroStim
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multi-center, triple-blinded, placebo-controlled, randomized clinical trial for adjunctive prophylactic treatment of episodic migraine headache (with or without aura) using neuromodulation device developed by Scion NeuroStim, LLC (SNS). The investigational use of the device for episodic migraine headache has been reviewed by the FDA and is classified as NSR (non-significant risk).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Denmark Hill
      • London, Denmark Hill, United Kingdom, SE5 9PJ
        • King's College London
    • Kent
      • Canterbury, Kent, United Kingdom, CT2 7NP
        • University of Kent
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • Florida
      • West Palm Beach, Florida, United States, 33407
        • Neurology Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60642
        • Diamond Headache Clinic
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Headache Pain & Neurological Inst.
    • Missouri
      • Saint Peters, Missouri, United States, 63303
        • Study Metrix Research
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Headache Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed with episodic migraine at least 6 months before study
  • at least 3 consecutive months of stable migraine headaches before study
  • at least 4-14 headache days per month, of which 4-14 may be migraines
  • must not have failed on more than 2 classes of migraine preventatives

Exclusion Criteria:

  • previous use of the experimental device
  • pregnant
  • using more than 1 concurrent migraine preventive
  • history of cardiovascular disease
  • work night shifts
  • diagnosed with vestibular migraine
  • menstrual migraines exclusively
  • diagnosed with post-traumatic migraine
  • have a history of unstable mood or anxiety disorder
  • use a hearing aid
  • have a cochlear implant
  • have chronic tinnitus
  • have temporomandibular joint disease
  • diagnosed with traumatic brain injury
  • diagnosed with neurological disease other than headaches
  • diagnosed vestibular and/or balance dysfunction
  • history of abusing alcohol or other drugs
  • are experiencing medication overuse headaches
  • have had eye surgery in the previous 3 months
  • have had ear surgery in the previous 6 months
  • have active ear infections or a perforated tympanic membrane
  • have participated in another clinical trial in the last 30 days
  • are currently participating in another clinical trial
  • using Botulinum toxin-based treatments for migraines or cosmetic reasons
  • taking anti-emetics more than 2 times per week (consistently)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: active
active neuromodulation
Device: active neuromodulation for episodic migraine headache
Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
Placebo Comparator: placebo
placebo neuromodulation
Device: placebo neuromodulation for episodic migraine headache
Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Migraine Headache Days (MHD)
Time Frame: 1 month of baseline recordation followed by 84 days of device use
comparison of MHD recorded in baseline month versus 3rd month of treatment
1 month of baseline recordation followed by 84 days of device use

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Normalized Reduction in Migraine Headache Days
Time Frame: 1 month of baseline recordation followed by 84 days of device use
comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo
1 month of baseline recordation followed by 84 days of device use
Change in Medication Usage
Time Frame: 1 month of baseline recordation followed by 84 days of device use
reduction in acute, prescribed medications in month 3 of treatment versus baseline month
1 month of baseline recordation followed by 84 days of device use
Change in Headache Pain
Time Frame: 1 month of baseline recordation followed by 84 days of device use
reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month
1 month of baseline recordation followed by 84 days of device use
Change in Quality of Life
Time Frame: 1 month of baseline recordation followed by 84 days of device use
comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3
1 month of baseline recordation followed by 84 days of device use
Change in Depression
Time Frame: 1 month of baseline recordation followed by 84 days of device use
comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3
1 month of baseline recordation followed by 84 days of device use
Change in Anxiety
Time Frame: 1 month of baseline recordation followed by 84 days of device use
comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3
1 month of baseline recordation followed by 84 days of device use
Change in Sleep Quality
Time Frame: 1 month of baseline recordation followed by 84 days of device use
comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3
1 month of baseline recordation followed by 84 days of device use
Additional Treatment Time
Time Frame: 1 month of baseline recordation followed by 168 days of device use
comparison of MHD recorded in baseline month versus 6th month of treatment
1 month of baseline recordation followed by 168 days of device use
Sustained Reduction in Migraine Headache Days
Time Frame: 1 month of baseline recordation followed by 252 days of device use
comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9
1 month of baseline recordation followed by 252 days of device use

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Scion NeuroStim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SNS-MIG-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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