Back to resultsNeurostimulation Device for Treatment of Migraine Headache
Primary Purpose
Migraine Headache
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TNM device
Sponsored by
About this trial
This is an interventional diagnostic trial for Migraine Headache
Eligibility Criteria
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.
Sites / Locations
- Duke Medicine / Neurology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TNM device, active treatment
Arm Description
This is an active-only assessment of the experimental neuromodulation device
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01630044
Brief Title
Neurostimulation Device for Treatment of Migraine Headache
Official Title
Clinical Pilot Study to Evaluate a Non-Invasive, Neurostimulation Device for Treatment of Migraine Headache
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scion NeuroStim
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TNM device, active treatment
Arm Type
Experimental
Arm Description
This is an active-only assessment of the experimental neuromodulation device
Intervention Type
Device
Intervention Name(s)
TNM device
Intervention Description
Non-invasive neurostimulator, home-use treatment for up to 43 days.
Primary Outcome Measure Information:
Title
Number of migraine headache days
Description
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.
Time Frame
Length of the study, about 71 days
Title
Severity of each and of all headaches
Description
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).
Time Frame
Length of study, 71 days
Secondary Outcome Measure Information:
Title
Total Monthly Headache Pain Score
Description
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.
Time Frame
Length of study, about 71 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Laskowitz, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Medicine / Neurology
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neurostimulation Device for Treatment of Migraine Headache
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