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Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04871581
Recruitment Status : Completed
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
ChairsideSplint.com

Study Description
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Brief Summary:
Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.

Condition or disease Intervention/treatment Phase
Chronic Migraine, Headache Device: NTI-tss Device: Placebo Not Applicable

Detailed Description:
In order to determine if nocturnal jaw clenching can be an influence on chronic migraine pain, the FDA cleared "NTI" (Nociceptive Trigeminal Inhibition) device with the Indications for Use of "for prophylactic treatment of medically diagnosed migraine pain" was compared to a similar device that had no influence on jaw clenching.The HIT-6 (Headache Impact Test) score was selected as the outcome measure, as the goal was to focus on improving disability in sufferer's lives, as in chronic migraine, changes in headache days may not be as helpful as improving disability.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single blinded cross-over study
Masking: Single (Participant)
Masking Description: Participants were advised that two different designs of device were being compared to each other.
Primary Purpose: Prevention
Official Title: Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device: Overview and Results of a Placebo-Controlled Crossover Study
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Device
Subjects receiving the FDA-cleared device
 Device: NTI-tss
FDA cleared device for prophylactic treatment of medically diagnosed migraine pain
Placebo Comparator: Placebo
Subjects receiving the sham device
 Device: Placebo
Similar to Device, but having no influence on clenching intensity


Outcome Measures
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Primary Outcome Measures :
  1. Improvement of negative impact on life [ Time Frame: one month ]
    At least a one-category improvement in subject's HIT-6 score


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Diagnosed with chronic migraine at a neurology clinic -

Exclusion Criteria: none

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04871581


Locations
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United States, California
Boyd James
Solana Beach, California, United States, 92075
Sponsors and Collaborators
ChairsideSplint.com
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ChairsideSplint.com
ClinicalTrials.gov Identifier: NCT04871581    
Other Study ID Numbers: NTI v Placebo
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by ChairsideSplint.com:
single blinded study
Additional relevant MeSH terms:
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Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations