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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02991430
Other study ID # SNS-MIG-02
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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