Clinical trial NCT04445766: Efficacy and Complications of Microvascular Decompression
Official title: Efficacy and Complications of Microvascular Decompression - a Prospective Systematic Study of 115 Trigeminal Neuralgia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigeminal Neuralgia
Keywords: neurosurgery
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We consecutively evaluated patients with the diagnosis of TN seen at the Danish Headache Center (DHC), a tertiary medical referral centre for headache and facial pain. Patients who were treated with MVD at the Department of Neurosurgery were included in the study.

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 2 years after microvascular decompression

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

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

Primary outcomes:
measure: Degree of pain relief 2 years after MVD
timeFrame: 2 years
measure: Degree of complication rate 2 years after MVD
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Andersen ASS, Heinskou TB, Rochat P, Springborg JB, Noory N, Smilkov EA, Bendtsen L, Maarbjerg S. Microvascular decompression in trigeminal neuralgia - a prospective study of 115 patients. J Headache Pain. 2022 Nov 19;23(1):145. doi: 10.1186/s10194-022-01520-x.