NCT05914558

Brief Summary

An observational study following up with trigeminal neuralgia patients to understand their comorbid facial pain condition, specifically temporomandibular disorder.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
4mo left

Started Aug 2022

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Aug 2022Aug 2026

Study Start

First participant enrolled

August 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

4.1 years

First QC Date

June 13, 2023

Last Update Submit

December 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence

    Prevalence of comorbid painful TMD among TN patient

    2 years

Secondary Outcomes (1)

  • Diagnostic questionnaire

    2 years

Study Arms (1)

TN cohort

The patient was diagnosed with trigeminal neuralgia which has active symptoms in the past 30 days.

Diagnostic Test: Clinical appointment

Interventions

Clinical appointmentDIAGNOSTIC_TEST

One clinical interview and examination to confirm the diagnosis of trigeminal neuralgia and temporomandibular disorder.

TN cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients that visited three clinical centers in the study who sought care for their facial pain were diagnosed with trigeminal neuralgia, with active symptoms in the past 30 days.

You may qualify if:

  • Patients visited the three clinical sites for facial pain
  • Patients diagnosed with trigeminal neuralgia
  • Has active pain symptoms in the past 30 days

You may not qualify if:

  • Non-English speakers
  • Patients with psychiatric disorders that might alter pain perception
  • Adults lack the capacity to provide informed consent.
  • Persons under the age of 18.
  • All vulnerable populations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

John Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Minnesota, Department of Neurosurgery

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Trigeminal NeuralgiaTemporomandibular Joint DisordersTrigeminal Nerve Diseases

Condition Hierarchy (Ancestors)

Facial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular Diseases

Study Officials

  • Donald Nixdorf, DDS,MS

    University of Minnesota

    PRINCIPAL INVESTIGATOR
  • Qiman Gao, DDS,MS,PhD

    University of Minnesota

    STUDY DIRECTOR
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Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

June 22, 2023

Study Start

August 1, 2022

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

December 31, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The final results will be shared with all the participants as a summary.

Shared Documents
CSR
Time Frame
By end of 2024

Locations