A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache

Intervention Clinical Trial

Official title:

A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02991430
• Other study ID #: SNS-MIG-02
• Status: Terminated
• Phase: N/A
• Start date: June 30, 2017
• Est. completion date: May 11, 2018

Study information

• Verified date: June 2019
• Source: Scion NeuroStim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: May 11, 2018
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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)

Related Conditions & MeSH terms

• Headache
• Intervention
• Migraine Disorders

Intervention

Device:
• active neuromodulation for episodic migraine headache
Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
• placebo neuromodulation for episodic migraine headache
Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical

Locations

Country	Name	City	State
United Kingdom	University of Kent	Canterbury	Kent
United Kingdom	King's College London	London	Denmark Hill
United States	Michigan Headache Pain & Neurological Inst.	Ann Arbor	Michigan
United States	Diamond Headache Clinic	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Jefferson Headache Center	Philadelphia	Pennsylvania
United States	Study Metrix Research	Saint Peters	Missouri
United States	Mayo Clinic	Scottsdale	Arizona
United States	Neurology Research Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Scion NeuroStim

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Migraine Headache Days (MHD)	comparison of MHD recorded in baseline month versus 3rd month of treatment	1 month of baseline recordation followed by 84 days of device use
Secondary	Normalized Reduction in Migraine Headache Days	comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo	1 month of baseline recordation followed by 84 days of device use
Secondary	Change in Medication Usage	reduction in acute, prescribed medications in month 3 of treatment versus baseline month	1 month of baseline recordation followed by 84 days of device use
Secondary	Change in Headache Pain	reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month	1 month of baseline recordation followed by 84 days of device use
Secondary	Change in Quality of Life	comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3	1 month of baseline recordation followed by 84 days of device use
Secondary	Change in Depression	comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3	1 month of baseline recordation followed by 84 days of device use
Secondary	Change in Anxiety	comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3	1 month of baseline recordation followed by 84 days of device use
Secondary	Change in Sleep Quality	comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3	1 month of baseline recordation followed by 84 days of device use
Secondary	Additional Treatment Time	comparison of MHD recorded in baseline month versus 6th month of treatment	1 month of baseline recordation followed by 168 days of device use
Secondary	Sustained Reduction in Migraine Headache Days	comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9	1 month of baseline recordation followed by 252 days of device use