Trigeminal NeuralgiaTNTMDNCT05914558
Comorbid Painful TMD Among Trigeminal Neuralgia
An observational study of Trigeminal Neuralgia and Temporomandibular Disorder, run by University of Minnesota at 2 sites in United States.
Trial summary
An observational study following up with trigeminal neuralgia patients to understand their comorbid facial pain condition, specifically temporomandibular disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia, Temporomandibular Disorder, Myofascial Pain
- What is being tested?
- Clinical appointment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2022to 30 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients visited the three clinical sites for facial pain
- Patients diagnosed with trigeminal neuralgia
- Has active pain symptoms in the past 30 days
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John Hopkins University
Baltimore, Maryland, 21287
University of Minnesota, Department of Neurosurgery
Minneapolis, Minnesota, 55455
About this study
Official title: Comorbid Painful Temporomandibular Disorder Among Trigeminal Neuralgia Patients
An observational study following up with trigeminal neuralgia patients to understand their comorbid facial pain condition, specifically temporomandibular disorder.
Read the detailed description
This multi-center prospective observational cohort study aims to investigate the prevalence of comorbid Temporomandibular disorders (TMD) among trigeminal neuralgia (TN) patients. Trigeminal neuralgia patients with active TN status from three clinical sites (University of Minnesota, School of Dentistry, Orofacial Pain Clinic; Mhealth Fairview, Clinical Surgical Center, Neurosurgery Clinic; John Hopkins University, Anesthesiology, and Critical Care Clinic) could enroll in this study voluntary. All the patients will be evaluated by a provider using standard clinical assessment for TN and TMD, along with validated RedCap questionnaires for TN and TMD diagnosis, and be followed up every six months for 1-2 years.
- Being tested
- Clinical appointment
- Medical subject headings
- Trigeminal Neuralgia, Temporomandibular Joint Disorders, Trigeminal Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical appointmentDiagnostic test
One clinical interview and examination to confirm the diagnosis of trigeminal neuralgia and temporomandibular disorder.
| Study group | Role | What they receive |
|---|---|---|
| TN cohort | The patient was diagnosed with trigeminal neuralgia which has active symptoms in the past 30 days. Receives: Diagnostic Test: Clinical appointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence
Prevalence of comorbid painful TMD among TN patient
Measured: 2 years
Secondary outcomes (1)
Diagnostic questionnaire
The sensitivity, specificity of the diagnostic questionnaire for TN and TMD
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Aug 2022
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Why it stopped: Due to lack of funding, we have been unable to continue research activities. The future related to funding support does not look promising, therefore it is best to discontinue this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Donald Nixdorf, DDS,MS, Principal investigator, University of MinnesotaQiman Gao, DDS,MS,PhD, Study director, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914558
- Sponsor's protocol ID
- UMN IRB No. 00008873
- Other IDs
- JHU IRB No. 00388974
- Acronym
- TNTMD
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final results will be shared with all the participants as a summary.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comorbid Painful Temporomandibular Disorder Among Trigeminal Neuralgia Patients
- ClinicalTrials.gov ID
- NCT05914558
- Acronym / sponsor ID
- TNTMD / UMN IRB No. 00008873
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to lack of funding, we have been unable to continue research activities. The future related to funding support does not look promising, therefore it is best to discontinue this project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study following up with trigeminal neuralgia patients to understand their comorbid facial pain condition, specifically temporomandibular disorder.
Detailed description
This multi-center prospective observational cohort study aims to investigate the prevalence of comorbid Temporomandibular disorders (TMD) among trigeminal neuralgia (TN) patients. Trigeminal neuralgia patients with active TN status from three clinical sites (University of Minnesota, School of Dentistry, Orofacial Pain Clinic; Mhealth Fairview, Clinical Surgical Center, Neurosurgery Clinic; John Hopkins University, Anesthesiology, and Critical Care Clinic) could enroll in this study voluntary. All the patients will be evaluated by a provider using standard clinical assessment for TN and TMD, along with validated RedCap questionnaires for TN and TMD diagnosis, and be followed up every six months for 1-2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TN cohort | – | Diagnostic Test: Clinical appointmentThe patient was diagnosed with trigeminal neuralgia which has active symptoms in the past 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients visited the three clinical sites for facial pain
- Patients diagnosed with trigeminal neuralgia
- Has active pain symptoms in the past 30 days
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical appointmentOne clinical interview and examination to confirm the diagnosis of trigeminal neuralgia and temporomandibular disorder. | Diagnostic test | TN cohort |
Primary outcome
Prevalence
Time frame: 2 years
Prevalence of comorbid painful TMD among TN patient
1 secondary outcome
Diagnostic questionnaire
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Yes. The final results will be shared with all the participants as a summary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Nixdorf, DDS,MS principal investigator
University of Minnesota
Qiman Gao, DDS,MS,PhD study director
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trigeminal Neuralgia and Temporomandibular Disorder, run by University of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.