Efficacy and Complications of Microvascular Decompression

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

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

Study Overview

• Status: Completed
• Conditions: Trigeminal Neuralgia

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.

• Study Type: Observational
• Enrollment (Actual): 115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Danish Headache Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2012
• Primary Completion (ACTUAL): October 31, 2020
• Study Completion (ACTUAL): October 31, 2020

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (ACTUAL): June 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: neurosurgery
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: H-16019808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No