- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07216547
- Original Trial
Post-Operative Trigeminal Pain After Microvascular Decompression for Trigeminal Neuralgia
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 Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sowmya Akkineni, BDS
- Phone Number: 540-408-7645
- Email: sowmyaakkineni19@gmail.com
Study Contact Backup
- Name: Sowmya Ananthan, BDS, DMD, MSD
- Phone Number: 732-322-8182
- Email: ananths1@sdm.rutgers.edu
Study Locations
-
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New Jersey
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Newark, New Jersey, United States, 07103
- Rutgers School of Dental Medicine
-
Contact:
- Sowmya Akkineni, BDS
- Phone Number: 540-408-7645
- Email: sowmyaakkineni19@gmail.com
-
Contact:
- Sowmya Ananthan, BDS, DMD, MSD
- Email: ananths1@sdm.rutgers.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- MVD post-operative patients with type I Trigeminal Neuralgia.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to 60 months post-surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gary Heir, DMD, Rutgers School of Dental Medicine
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Mouth Diseases
- Stomatognathic Diseases
- Nervous System Diseases
- Postoperative Complications
- Pathologic Processes
- Cranial Nerve Diseases
- Trigeminal Nerve Diseases
- Facial Neuralgia
- Facial Nerve Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Trigeminal Neuralgia
Other Study ID Numbers
- Pro2025001535
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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