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OpenTrials
Completed

NCT Number: NCT04871581

Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device

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

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Key information

Conditions

Chronic Migraine, Headache Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boyd James

Solana Beach, California, 92075, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed with chronic migraine at a neurology clinic -

Exclusion criteria

none

-

Treatment and study plan

NTI-tss

Device

FDA cleared device for prophylactic treatment of medically diagnosed migraine pain

PLACEBO

Device

Similar to Device, but having no influence on clenching intensity

Primary outcomes

  1. Improvement of negative impact on life

    Time frame: one month

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

Sponsors and collaborators

Lead sponsor

ChairsideSplint.com

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 4, 2021
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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