NCT04871581

Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device

Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device: Overview and Results of a Placebo-Controlled Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: ChairsideSplint.com · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Migraine, Headache

Interventions

Type	Name	Description
DEVICE	NTI-tss	FDA cleared device for prophylactic treatment of medically diagnosed migraine pain
DEVICE	Placebo	Similar to Device, but having no influence on clenching intensity

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2021-05-04
• Last updated: 2021-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study