Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device

Not Applicable

Completed

• Conditions: Chronic Migraine, Headache
• Interventions: Device: NTI-tss; Device: Placebo

• Registration Number: NCT04871581
• Lead Sponsor: ChairsideSplint.com

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.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2021-04
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Last Update Submitted: 2021-04-29
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Diagnosed with chronic migraine at a neurology clinic -

Exclusion Criteria

none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Device	NTI-tss	Subjects receiving the FDA-cleared device
Placebo	Placebo	Subjects receiving the sham device

Primary Outcome Measures

Name	Time	Method
Improvement of negative impact on life	one month	At least a one-category improvement in subject's HIT-6 score

Trial Locations

Locations (1)

Boyd James; 🇺🇸 Solana Beach, California, United States