Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - a Prospective Study in 60 Patients

April 29, 2020 updated by: Stine Maarbjerg, MD PhD

Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - Clinical Characteristics, Neuroanatomical Abnormalities and Treatment Efficacy

Clinical characteristics, neuroanatomical findings and efficacy of medical and surgical treatment of symptomatic trigeminal neuralgia - a systematic prospective study of 60 consecutive patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background Among patients with TN, approximately 15% has secondary TN caused by another underlying condition such as multiple sclerosis or a tumor. Studies of classical TN patients have shown a strong association between a severe NVC of the trigeminal nerve and the painful side. This association has been less investigated in STN.

There are no previous systemic and prospective studies of the underlying causes, characteristics and treatment response of patients with STN. Most existing studies on STN have various methodological drawbacks as inclusion was not prospective, diagnosis was not consistent with international guidelines, imaging techniques were not adequately advanced at the time of publication and evaluation of treatment efficacy was not performed by evaluators independent of the neurosurgeon.

Aims

1) To describe the clinical characteristics, the neuroanatomical findings using 3.0 Tesla MRI, and the efficacy of medical and surgical treatment in STN

Hypotheses

  1. In STN, there is a correlation between demylinating brainstem plaques and presence and degree of neurovascular contact of the trigeminal nerve ipsilateral to the painful side
  2. The efficacy of medical and surgical treatment of STN is comparable to the efficacy in patients with classical trigeminal neuralgia

Power calculations Sample size depends on the number of patients in the inclusion period. The estimated number of included patients is at least 60 patients.

Methods Data have been collected prospectively since 2012 based on semi-structured interview forms completed at out-patient visits at the Danish Headache Center. The efficacy of medical and surgical treatment was also documented prospectively by structured interviews. Efficacy of surgical treatment was evaluated by independent assessors.

All patients had a 3.0 Tesla MRI with a special protocol adapted for the trigeminal nerve and the brainstem.

Ethical considerations The treatment of patients with STN will not differ from the usual treatment and decision-taking.

Study Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical cohort of patients diagnosed with secondary trigeminal neuralgia attributed to multiple sclerosis at the Danish Headache Center

Description

Inclusion Criteria:

  • Diagnosis of secondary trigeminal neuralgia attributed to multiple sclerosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demyelinating brainstem plaques and neurovascular contact
Time Frame: 2012-2019
In STN, there is a correlation between demyelinating brainstem plaques and presence and degree of neurovascular contact of the trigeminal nerve ipsilateral to the painful side
2012-2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stine Maarbjerg, MD PhD

Investigators

  • Principal Investigator: Lars Bendtsen, Dr Med Sci, Danish Headache Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2012

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

April 29, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (ACTUAL)

May 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 1, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010919

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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