Efficacy and Complications of Microvascular Decompression

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445766
• Other study ID #: H-16019808
• Status: Completed
• Start date: May 1, 2012
• Est. completion date: October 31, 2020

Study information

• Verified date: March 2022
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Outcome

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