NCT07216547

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress86%
Dec 2025Jun 2026

First Submitted

Initial submission to the registry

October 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

December 12, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

6 months

First QC Date

October 10, 2025

Last Update Submit

October 10, 2025

Conditions

Keywords

post operative relapse

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 60 months post-surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • MVD post-operative patients with type I Trigeminal Neuralgia.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Trigeminal NeuralgiaPain, Postoperative

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gary Heir, DMD

    Rutgers School of Dental Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sowmya Akkineni, BDS

CONTACT

Sowmya Ananthan, BDS, DMD, MSD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Program and Clinical Director

Study Record Dates

First Submitted

October 10, 2025

First Posted

October 14, 2025

Study Start

December 12, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

October 14, 2025

Record last verified: 2025-10

Locations