Neurostimulation Device for Treatment of Migraine Headache

Study Overview
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Brief Summary
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This is a prospective, non-randomized and unblinded study designed to generate preliminary data to assess the effect of a new portable non-invasive brainstem stimulator to treat migraine headaches in patients with episodic migraine headaches.

Detailed Description
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This study is a single-center, unblinded, non-randomized clinical trial for adjunctive prophylactic treatment of episodic migraine headache 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).

Official Title
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Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache

Conditions
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Migraine Headache

Intervention / Treatment
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* Device: TNM device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: On a Monthly basis, at least four, and not more than a total of fourteen Headache Days (Pain Score between one and ten) of which between four and nine are Migraine Headache Days (Pain Score between five and ten). NOTE: For clarification, the occurrence of Headaches is counted taking into account, and making no adjustments for, the medications that the subjects are taking; A history of some responsiveness (incomplete) to at least one and a maximum of two prophylactic pharmaceutical therapies (utilized concurrently); The investigator must have confidence in the patient's ability to reliably complete and return the Daily Headache Diary. Subject must be at least 18 years of age. Exclusion Criteria: Individuals who are pregnant, who have a history of cardiovascular disease, who work night shifts or who have vestibular migraine, menstrual migraine, posttraumatic migraine, a history of unstable mood disorder or unstable anxiety, moderate or greater hearing loss or a history of traumatic brain injury will be excluded from the Study. A history within the last six months of tobacco use, narcotic or barbiturates use or experiencing one or more analgesic rebound headaches.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNM device, active treatment<br>This is an active-only assessment of the experimental neuromodulation device | Device: TNM device<br>* Non-invasive neurostimulator, home-use treatment for up to 43 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of migraine headache days | Daily Headache Diary will be used by subject. A headache day is defined as a twenty-four hour period which the subject has a headache. | Length of the study, about 71 days | 
| Severity of each and of all headaches | Daily Headache Diary will be used by subject. Subject will assign the level of pain based on an eleven-point pain measurement scale from zero (no pain) to ten (most intense pain). | Length of study, 71 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Monthly Headache Pain Score | The monthly measure would be the cumulative maximal headache pain scores for all headache days (days on which the subject's head pain level is one or higher on the pain measurement scale) during the month. | Length of study, about 71 days |