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CompletedNCT04871581Updated May 4, 2021

Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device

An interventional study of NTI-tss and Placebo in Chronic Migraine, Headache, sponsored by ChairsideSplint.com. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-04.

Sponsored by ChairsideSplint.com · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Jun 2020, 6 years 3 months ago, and no results have been posted to the registry.
  • Registered 1 year 6 months after the study started (first participant enrolled Oct 2019, registered Apr 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.

Read the 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.

02

Conditions studied

  • Chronic Migraine, Headache

Keywords

  • single blinded study
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 25 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

This is the only study on the registry with ChairsideSplint.com as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

Exclusion Criteria: none

-

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Device

    Subjects receiving the FDA-cleared device

    Device: NTI-tss

  • Placebo comparator
    Placebo

    Subjects receiving the sham device

    Device: Placebo

Interventions

  • DeviceNTI-tss

    FDA cleared device for prophylactic treatment of medically diagnosed migraine pain

  • DevicePlacebo

    Similar to Device, but having no influence on clenching intensity

06

What researchers measure

Primary outcomes

  1. Improvement of negative impact on life

    At least a one-category improvement in subject's HIT-6 score

    Time frame: one month

07

Study locations

1 site
  • Boyd James
    Solana Beach, California 92075, United States
08

References and documents

Publications

  • Silberstein SD, Lipton RB. Chronic daily headache. Curr Opin Neurol. 2000 Jun;13(3):277-83. doi: 10.1097/00019052-200006000-00008. PubMed 10871251 ↗
  • Pascual J, Colas R, Castillo J. Epidemiology of chronic daily headache. Curr Pain Headache Rep. 2001 Dec;5(6):529-36. doi: 10.1007/s11916-001-0070-6. PubMed 11676887 ↗
  • Rozen TD. Migraine prevention: what patients want from medication and their physicians (a headache specialty clinic perspective). Headache. 2006 May;46(5):750-3. doi: 10.1111/j.1526-4610.2006.00429.x. PubMed 16643577 ↗
  • Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. doi: 10.1111/j.1526-4610.2005.4501003.x. PubMed 15833086 ↗
  • 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. doi: 10.1007/s11916-002-0081-y. PubMed 12207852 ↗
  • 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. doi: 10.1111/j.1365-2842.1991.tb01690.x. PubMed 1800695 ↗
  • Lamey PJ, Barclay SC. Clinical effectiveness of occlusal splint therapy in patients with classical migraine. Scott Med J. 1987 Feb;32(1):11-2. doi: 10.1177/003693308703200105. PubMed 3563468 ↗
  • 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. PubMed 9656905 ↗
  • Graff-Radford SB. Oromandibular disorders and headache. A critical appraisal. Neurol Clin. 1990 Nov;8(4):929-45. PubMed 2259320 ↗
  • 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. PubMed 27656052 ↗
  • 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. doi: 10.1046/j.1526-4610.2000.00147.x. PubMed 11135025 ↗
  • 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. doi: 10.1111/j.1365-2842.2004.01377.x. PubMed 15189309 ↗
  • Nishigawa K, Bando E, Nakano M. Quantitative study of bite force during sleep associated bruxism. J Oral Rehabil. 2001 May;28(5):485-91. doi: 10.1046/j.1365-2842.2001.00692.x. PubMed 11380790 ↗
  • Castillo J, Munoz P, Guitera V, Pascual J. Kaplan Award 1998. Epidemiology of chronic daily headache in the general population. Headache. 1999 Mar;39(3):190-6. doi: 10.1046/j.1526-4610.1999.3903190.x. PubMed 15613213 ↗
  • 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. PubMed 35246048 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04871581
Lead sponsor
ChairsideSplint.com
Responsible party
Sponsor
First posted
May 4, 2021
Start date
Oct 1, 2019
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
May 4, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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