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

Primary Purpose

Intervention

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
active neuromodulation for episodic migraine headache
placebo neuromodulation for episodic migraine headache
Sponsored by
Scion NeuroStim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intervention focused on measuring migraine headache, episodic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic
  • Neurology Research Institute
  • Diamond Headache Clinic
  • Michigan Headache Pain & Neurological Inst.
  • Study Metrix Research
  • Dartmouth-Hitchcock Medical Center
  • Cleveland Clinic
  • Jefferson Headache Center
  • King's College London
  • University of Kent

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

active

placebo

Arm Description

active neuromodulation

placebo neuromodulation

Outcomes

Primary Outcome Measures

Change in Migraine Headache Days (MHD)
comparison of MHD recorded in baseline month versus 3rd month of treatment

Secondary Outcome Measures

Normalized Reduction in Migraine Headache Days
comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo
Change in Medication Usage
reduction in acute, prescribed medications in month 3 of treatment versus baseline month
Change in Headache Pain
reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month
Change in Quality of Life
comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3
Change in Depression
comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3
Change in Anxiety
comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3
Change in Sleep Quality
comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3
Additional Treatment Time
comparison of MHD recorded in baseline month versus 6th month of treatment
Sustained Reduction in Migraine Headache Days
comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9

Full Information

First Posted
December 4, 2016
Last Updated
June 15, 2019
Sponsor
Scion NeuroStim
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1. Study Identification

Unique Protocol Identification Number
NCT02991430
Brief Title
A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
Official Title
A Non-Invasive Neuromodulation Device for Prevention of Episodic Migraine Headache
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Inability to supply and maintain treatment device. No safety concerns occurred.
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
May 11, 2018 (Actual)
Study Completion Date
May 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scion NeuroStim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervention
Keywords
migraine headache, episodic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active
Arm Type
Active Comparator
Arm Description
active neuromodulation
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo neuromodulation
Intervention Type
Device
Intervention Name(s)
active neuromodulation for episodic migraine headache
Intervention Description
Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
Intervention Type
Device
Intervention Name(s)
placebo neuromodulation for episodic migraine headache
Intervention Description
Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical
Primary Outcome Measure Information:
Title
Change in Migraine Headache Days (MHD)
Description
comparison of MHD recorded in baseline month versus 3rd month of treatment
Time Frame
1 month of baseline recordation followed by 84 days of device use
Secondary Outcome Measure Information:
Title
Normalized Reduction in Migraine Headache Days
Description
comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo
Time Frame
1 month of baseline recordation followed by 84 days of device use
Title
Change in Medication Usage
Description
reduction in acute, prescribed medications in month 3 of treatment versus baseline month
Time Frame
1 month of baseline recordation followed by 84 days of device use
Title
Change in Headache Pain
Description
reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month
Time Frame
1 month of baseline recordation followed by 84 days of device use
Title
Change in Quality of Life
Description
comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3
Time Frame
1 month of baseline recordation followed by 84 days of device use
Title
Change in Depression
Description
comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3
Time Frame
1 month of baseline recordation followed by 84 days of device use
Title
Change in Anxiety
Description
comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3
Time Frame
1 month of baseline recordation followed by 84 days of device use
Title
Change in Sleep Quality
Description
comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3
Time Frame
1 month of baseline recordation followed by 84 days of device use
Title
Additional Treatment Time
Description
comparison of MHD recorded in baseline month versus 6th month of treatment
Time Frame
1 month of baseline recordation followed by 168 days of device use
Title
Sustained Reduction in Migraine Headache Days
Description
comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9
Time Frame
1 month of baseline recordation followed by 252 days of device use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Neurology Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60642
Country
United States
Facility Name
Michigan Headache Pain & Neurological Inst.
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Study Metrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Jefferson Headache Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
King's College London
City
London
State/Province
Denmark Hill
ZIP/Postal Code
SE5 9PJ
Country
United Kingdom
Facility Name
University of Kent
City
Canterbury
State/Province
Kent
ZIP/Postal Code
CT2 7NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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