Trigeminal NeuralgiaNCT07216547
Post-Operative Trigeminal Pain After Microvascular Decompression for Trigeminal Neuralgia
An observational study of Trigeminal Neuralgia and Microvascular Decompression Surgery, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this observational study is to learn about the long-term effects of microvascular decompression (MVD) in patients with trigeminal neuralgia (TN). The main question it aims to answer is: Does undergoing post-operative dental treatment or other orofacial stimulation increase the likelihood of pain relapse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia, Microvascular Decompression Surgery, Post-operative Pain
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Potential participants will be identified through a review of the post-operative patient database at Robert Wood Johnson University Hospital in New Brunswick, New Jersey. Eligible subjects are individuals who have undergone initial microvascular decompression (MVD) surgery for trigeminal neuralgia. Medical records will be accessed through the EPIC system, with IRB approval in place
Who may be able to join
- MVD post-operative patients with type I Trigeminal Neuralgia.
Who cannot join
- Atypical (Type II) Facial Pain at presentation, revision surgery.
- Patients who are unable or unwilling to provide informed consent will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Rutgers School of Dental Medicine
Newark, New Jersey, 07103
Sowmya Akkineni, BDS, 540-408-7645, sowmyaakkineni19@gmail.com
Sowmya Ananthan, BDS, DMD, MSD, ananths1@sdm.rutgers.edu
About this study
The goal of this observational study is to learn about the long-term effects of microvascular decompression (MVD) in patients with trigeminal neuralgia (TN). The main question it aims to answer is:
Does undergoing post-operative dental treatment or other orofacial stimulation increase the likelihood of pain relapse after MVD for TN?
Participants who have previously undergone MVD for TN as part of their standard medical care will be asked to complete surveys over phone call. These surveys will focus on their pain experiences, timing, anxiety attacks and nature of any pain relapses, and whether they have received dental treatments or other orofacial interventions during follow-up.
- Keywords
- post operative relapse
- Medical subject headings
- Trigeminal Neuralgia, Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain control following microvascular decompression (MVD)
Pain control will be assessed using the Barrow Neurological Institute (BNI) Pain Scale to evaluate changes in pain severity and relief after MVD.
Measured: Up to 60 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start12 Dec 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
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 Rutgers, The State University of New JerseyThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary M. Heir, DMD, Rutgers, The State University of New Jersey
- Investigators
- Gary Heir, DMD, Principal investigator, Rutgers School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216547
- Sponsor's protocol ID
- Pro2025001535
- Status last verified
- Oct 2025
- First submitted
- 10 Oct 2025
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Trigeminal Pain After Microvascular Decompression for Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT07216547
- Acronym / sponsor ID
- Pro2025001535
- Keywords
- post operative relapse
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 12 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 14 Oct 2025 (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.
The goal of this observational study is to learn about the long-term effects of microvascular decompression (MVD) in patients with trigeminal neuralgia (TN). The main question it aims to answer is:
Does undergoing post-operative dental treatment or other orofacial stimulation increase the likelihood of pain relapse after MVD for TN?
Participants who have previously undergone MVD for TN as part of their standard medical care will be asked to complete surveys over phone call. These surveys will focus on their pain experiences, timing, anxiety attacks and nature of any pain relapses, and whether they have received dental treatments or other orofacial interventions during follow-up.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participants will be identified through a review of the post-operative patient database at Robert Wood Johnson University Hospital in New Brunswick, New Jersey. Eligible subjects are individuals who have undergone initial microvascular decompression (MVD) surgery for trigeminal neuralgia. Medical records will be accessed through the EPIC system, with IRB approval in place
Key inclusion criteria (1 listed)
- MVD post-operative patients with type I Trigeminal Neuralgia.
Key exclusion criteria (2 listed)
- Atypical (Type II) Facial Pain at presentation, revision surgery.
- Patients who are unable or unwilling to provide informed consent will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain control following microvascular decompression (MVD)
Time frame: Up to 60 months post-surgery
Pain control will be assessed using the Barrow Neurological Institute (BNI) Pain Scale to evaluate changes in pain severity and relief after MVD.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
Gary Heir, DMD principal investigator
Rutgers School of Dental Medicine
1 site 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 Microvascular Decompression Surgery, run by Rutgers, The State University of New Jersey at 1 site 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sowmya Akkineni, BDS (540-408-7645, sowmyaakkineni19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain control following microvascular decompression (MVD) (time frame: Up to 60 months post-surgery). 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 14 Oct 2025.