Efficacy, Safety, and Tolerability of SR750 in Patients With Trigeminal Neuralgia
NCT06571448
Cranial Nerve Diseases, Facial Nerve Diseases
Beijing, China
View Trial DetailsNCT Number: NCT04445766
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 2 years after microvascular decompression
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Notify Me18 year–85 year
All sexes
Observational
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 prospectively based on based on standardized follow-up schemes and questionnaires. Patients were assessed by independent assessors before surgery and 3, 6, 12 and 24 months after surgery. Current pain level was evaluated according to VAS and BNI pain scale. Complications were evaluated by the assessors by a questionnaire and physical examination. All patients undergo a pre-surgical protocolized 3.0 Tesla MRI of the brain and brainstem.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be excluded if one of the following exclusion criteria is met:
Time frame: 2 years
Barrow Neurological Institute pain intensity score (BNI)
Time frame: 2 years
The frequency of predefined major and minor complications
Danish Headache Center
Other
Efficacy and Complications of Microvascular Decompression - a Prospective Systematic Study of 115 Trigeminal Neuralgia Patients
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