Neurostimulation Device for Treatment of Migraine Headache

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine Headache
• Intervention / Treatment: Device: TNM device

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Medicine / Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Scion NeuroStim
• Investigators: Principal Investigator: Daniel Laskowitz, MD, Duke University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: June 5, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): December 22, 2016
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: Pro00037089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No