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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04371575
Other study ID # 010919
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2012
Est. completion date December 31, 2019

Study information

Verified date April 2020
Source Danish Headache Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosis of secondary trigeminal neuralgia attributed to multiple sclerosis

Study Design


Intervention

Drug:
Carbamazepine
There is no actual intervention as the study is observational. First choice tratment is Carbamzepine and Oxcarbazepine. In medically refractory patients, first choice surgery is microvascular decompression

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Stine Maarbjerg, MD PhD

Outcome

Type Measure Description Time frame Safety issue
Primary Demyelinating brainstem plaques and neurovascular contact 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
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