Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device

ChairsideSplint.com

Status: Completed

Conditions: Chronic Migraine, Headache

Treatments: Device: Placebo; Device: NTI-tss

Study type: Interventional

Funder types: Industry

Identifiers

NCT04871581

NTI v Placebo

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria: none

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups, including a placebo group

Device

Active Comparator group

Description:

Subjects receiving the FDA-cleared device

Treatment:

Device: NTI-tss

Placebo

Placebo Comparator group

Description:

Subjects receiving the sham device

Treatment:

Device: Placebo