Efficacy and Complications of Microvascular Decompression

Efficacy and Complications of Microvascular Decompression - a Prospective Systematic Study of 115 Trigeminal Neuralgia Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04445766

Enrollment

115

Registered

2020-06-24

Start date

2012-05-01

Completion date

2020-10-31

Last updated

2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Neuralgia

Keywords

neurosurgery

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Degree of pain relief 2 years after MVD	2 years	Barrow Neurological Institute pain intensity score (BNI)
Degree of complication rate 2 years after MVD	2 years	The frequency of predefined major and minor complications

Outcome results