Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device
Sponsor
ChairsideSplint.com (Industry)
Overall Status
Completed
CT.gov ID
NCT04871581
Collaborator
(none)
25
1
2
9
2.8
Study Details
Study Description
Brief Summary
Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Type:
Interventional
Actual Enrollment
:
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Single blinded cross-over studySingle 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
:
Oct 1, 2019
Actual Primary Completion Date
:
Jun 30, 2020
Actual Study Completion Date
:
Jun 30, 2020
Arms and Interventions
| 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
Primary Outcome Measures
- Improvement of negative impact on life [one month]
At least a one-category improvement in subject's HIT-6 score
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria: Diagnosed with chronic migraine at a neurology clinic -
Exclusion Criteria: none
-
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boyd James | Solana Beach | California | United States | 92075 |
Sponsors and Collaborators
- ChairsideSplint.com
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Burnett CA, Fartash L, Murray B, Lamey PJ. Masseter and temporalis muscle EMG levels and bite force in migraineurs. Headache. 2000 Nov-Dec;40(10):813-7.
- Chandu A, Suvinen TI, Reade PC, Borromeo GL. The effect of an interocclusal appliance on bite force and masseter electromyography in asymptomatic subjects and patients with temporomandibular pain and dysfunction. J Oral Rehabil. 2004 Jun;31(6):530-7.
- Clark GT, Sakai S, Merrill R, Flack VF, McArthur D, McCreary C. Waking and sleeping temporalis EMG levels in tension-type headache patients. J Orofac Pain. 1997 Fall;11(4):298-306.
- Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. Review.
- Graff-Radford SB, Newman AC. The role of temporomandibular disorders and cervical dysfunction in tension-type headache. Curr Pain Headache Rep. 2002 Oct;6(5):387-91. Review.
- Graff-Radford SB. Oromandibular disorders and headache. A critical appraisal. Neurol Clin. 1990 Nov;8(4):929-45. Review.
- Lamey PJ, Barclay SC. Clinical effectiveness of occlusal splint therapy in patients with classical migraine. Scott Med J. 1987 Feb;32(1):11-2.
- Nishigawa K, Bando E, Nakano M. Quantitative study of bite force during sleep associated bruxism. J Oral Rehabil. 2001 May;28(5):485-91.
- Pascual J, Colás R, Castillo J. Epidemiology of chronic daily headache. Curr Pain Headache Rep. 2001 Dec;5(6):529-36. Review.
- Rozen TD. Migraine prevention: what patients want from medication and their physicians (a headache specialty clinic perspective). Headache. 2006 May;46(5):750-3.
- Silberstein SD, Lipton RB. Chronic daily headache. Curr Opin Neurol. 2000 Jun;13(3):277-83. Review.
- Steele JG, Lamey PJ, Sharkey SW, Smith GM. Occlusal abnormalities, pericranial muscle and joint tenderness and tooth wear in a group of migraine patients. J Oral Rehabil. 1991 Sep;18(5):453-8.
- Yap AU, Chua AP. Sleep bruxism: Current knowledge and contemporary management. J Conserv Dent. 2016 Sep-Oct;19(5):383-9. doi: 10.4103/0972-0707.190007. Review.
Responsible Party:
ChairsideSplint.com
ClinicalTrials.gov Identifier:
NCT04871581
Other Study ID Numbers:
- NTI v Placebo
First Posted:
May 4, 2021
Last Update Posted:
May 4, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms: