Back to resultsAdjunctive Treatment of Chronic Migraine Using an Oral Dental Device
Primary Purpose
Chronic Migraine, Headache
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NTI-tss
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Migraine, Headache focused on measuring single blinded study
Eligibility Criteria
Inclusion Criteria: Diagnosed with chronic migraine at a neurology clinic -
Exclusion Criteria: none
-
Sites / Locations
- Boyd James
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Device
Placebo
Arm Description
Subjects receiving the FDA-cleared device
Subjects receiving the sham device
Outcomes
Primary Outcome Measures
Improvement of negative impact on life
At least a one-category improvement in subject's HIT-6 score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04871581
Brief Title
Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device
Official Title
Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device: Overview and Results of a Placebo-Controlled Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ChairsideSplint.com
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Headache
Keywords
single blinded study
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single blinded cross-over study
Masking
Participant
Masking Description
Participants were advised that two different designs of device were being compared to each other.
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device
Arm Type
Active Comparator
Arm Description
Subjects receiving the FDA-cleared device
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects receiving the sham device
Intervention Type
Device
Intervention Name(s)
NTI-tss
Intervention Description
FDA cleared device for prophylactic treatment of medically diagnosed migraine pain
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
Similar to Device, but having no influence on clenching intensity
Primary Outcome Measure Information:
Title
Improvement of negative impact on life
Description
At least a one-category improvement in subject's HIT-6 score
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosed with chronic migraine at a neurology clinic -
Exclusion Criteria: none
-
Facility Information:
Facility Name
Boyd James
City
Solana Beach
State/Province
California
ZIP/Postal Code
92075
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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10871251
Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
Blumenfeld AM, Boyd JP. Adjunctive treatment of chronic migraine using an oral dental device: overview and results of a randomized placebo-controlled crossover study. BMC Neurol. 2022 Mar 4;22(1):72. doi: 10.1186/s12883-022-02591-8.
Results Reference
derived
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Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device
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