InterventionNCT02991430
A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
A study testing active neuromodulation for episodic migraine headache in people with Intervention, run by Scion NeuroStim at 10 sites in 2 countries.
Trial summary
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intervention
- What is being tested?
- active neuromodulation for episodic migraine headache
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 30 Jun 2017to 11 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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)
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Michigan Headache Pain & Neurological Inst.
Ann Arbor, Michigan, 48104
Diamond Headache Clinic
Chicago, Illinois, 60642
Study Metrix Research
City of Saint Peters, Missouri, 63303
Cleveland Clinic
Cleveland, Ohio, 44195
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Scottsdale, Arizona, 85259
Neurology Research Institute
West Palm Beach, Florida, 33407
United Kingdom2 sites
University of Kent
Canterbury, Kent, CT2 7NP
King's College London
London, Denmark Hill, SE5 9PJ
About this study
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.
Read the 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).
- Conditions
- Intervention
- Being tested
- active neuromodulation for episodic migraine headache, placebo neuromodulation for episodic migraine headache
- Keywords
- migraine headache, episodic
- Medical subject headings
- Migraine Disorders, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active neuromodulation for episodic migraine headacheDevice
Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
placebo neuromodulation for episodic migraine headacheDevice
Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical
| Study group | Role | What they receive |
|---|---|---|
| active | Active comparator | active neuromodulation Receives: Device: active neuromodulation for episodic migraine headache |
| placebo | Placebo comparator | placebo neuromodulation Receives: Device: placebo neuromodulation for episodic migraine headache |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Migraine Headache Days (MHD)
comparison of MHD recorded in baseline month versus 3rd month of treatment
Measured: 1 month of baseline recordation followed by 84 days of device use
Secondary outcomes (9)
Normalized Reduction in Migraine Headache Days
comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo
Measured: 1 month of baseline recordation followed by 84 days of device use
Change in Medication Usage
reduction in acute, prescribed medications in month 3 of treatment versus baseline month
Measured: 1 month of baseline recordation followed by 84 days of device use
Change in Headache Pain
reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month
Measured: 1 month of baseline recordation followed by 84 days of device use
Change in Quality of Life
comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3
Measured: 1 month of baseline recordation followed by 84 days of device use
Change in Depression
comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3
Measured: 1 month of baseline recordation followed by 84 days of device use
Change in Anxiety
comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3
Measured: 1 month of baseline recordation followed by 84 days of device use
Change in Sleep Quality
comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3
Measured: 1 month of baseline recordation followed by 84 days of device use
Additional Treatment Time
comparison of MHD recorded in baseline month versus 6th month of treatment
Measured: 1 month of baseline recordation followed by 168 days of device use
Sustained Reduction in Migraine Headache Days
comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9
Measured: 1 month of baseline recordation followed by 252 days of device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start30 Jun 2017
- Primary completion11 May 2018
- Study completion11 May 2018
Why it stopped: Inability to supply and maintain treatment device. No safety concerns occurred.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scion NeuroStim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991430
- Sponsor's protocol ID
- SNS-MIG-02
- Status last verified
- Jun 2019
- First submitted
- 4 Dec 2016
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
- ClinicalTrials.gov ID
- NCT02991430
- Acronym / sponsor ID
- SNS-MIG-02
- Conditions
- Intervention
- Keywords
- migraine headache, episodic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to supply and maintain treatment device. No safety concerns occurred.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Scion NeuroStimIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active | Active comparator | Device: active neuromodulation for episodic migraine headacheactive neuromodulation |
| placebo | Placebo comparator | Device: placebo neuromodulation for episodic migraine headacheplacebo neuromodulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (25 listed)
- previous use of the experimental device
- pregnant
- using more than 1 concurrent migraine preventive
- history of cardiovascular disease
- work night shifts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active neuromodulation for episodic migraine headacheNon-invasive brainstem neuromodulator. Active and placebo devices appear identical | Device | active |
| placebo neuromodulation for episodic migraine headacheSham non-invasive brainstem neuromodulator. Active and placebo devices appear identical | Device | placebo |
Primary outcome
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
9 secondary outcomes
Normalized Reduction in Migraine Headache Days
Time frame: 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
Change in Headache Pain
Time frame: 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
Change in Depression
Time frame: 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
Change in Sleep Quality
Time frame: 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
Sustained Reduction in Migraine Headache Days
Time frame: 1 month of baseline recordation followed by 252 days of device use
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active neuromodulation for episodic migraine headache in people with Intervention, run by Scion NeuroStim at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Migraine Headache Days (MHD) (time frame: 1 month of baseline recordation followed by 84 days of device use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.