Neurostimulation Device for Treatment of Migraine Headache

Migraine Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630044
• Other study ID #: Pro00037089
• Status: Completed
• Phase: N/A
• First received: June 5, 2012
• Last updated: December 20, 2016
• Start date: May 2012
• Est. completion date: April 2013

Study information

• Verified date: December 2016
• Source: Scion NeuroStim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Device:
• TNM device
Non-invasive neurostimulator, home-use treatment for up to 43 days.

Locations

Country	Name	City	State
United States	Duke Medicine / Neurology	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Scion NeuroStim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No