Status:
COMPLETED
Efficacy and Complications of Microvascular Decompression
Lead Sponsor:
Danish Headache Center
Conditions:
Trigeminal Neuralgia
Eligibility:
All Genders
18-85 years
Brief Summary
The study is a non-interventional prospective observational study in patients with trigeminal neuralgia that undergoes micovascular decompression. The aim is to evaluate the efficacy and complications...
Detailed Description
The aim of this study is to prospectively evaluate effect and complications 2 years after MVD using independent assessors of outcome and complications. Data of outcome and complications is collected ...
Eligibility Criteria
Inclusion
- Age 18 years or older.
- Most give Signed informed Consent.
- Must fullfil the ICHD-3 beta diagnostic criteria for classical TN.Patients with purely paroxysmal TN and patients with TN with concomitant persistent facial pain will be included.
- If the ICHD-3 beta diagnostic criteria is fulfilled and if complete clinical history, neurological and physical examination and a 3.0 Tesla MRI do not raise any suspicion of another causative disease such as painful posttraumatic trigeminal neuropathy or symptomatic TN, subjects with sensory abnormalities detected at clinical neurological examination are also included.
- Has had a 3.0 Tesla MRI according to the trigeminal neuralgia protocol, prior to the surgical intervention.
- Semi-structured interview and neurological examination by the independent assessors prior to neurosurgical intervention.
- Has tried at least one, preferably two, sodium channel blocker (either carbamazepine or oxcarbazepine) before referral to neurosurgery.
Exclusion
- Subjects will be excluded if one of the following exclusion criteria is met:
- Psychiatric or mental illness or condition that might interfere with the ability of the patients to fill in the Informed Consent and questionnaires.
- Previous microvascular decompression as a treatment for trigeminal neuralgia
Key Trial Info
Start Date :
May 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04445766
Start Date
May 1 2012
End Date
October 31 2020
Last Update
August 7 2024
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