Efficacy and Complications of Microvascular Decompression

NCT ID: NCT04445766

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-01
• Study Completion Date: 2020-10-31

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.

Conditions

Trigeminal Neuralgia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Lars Bendtsen

MD, PhD, Dr Med Sci

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 36402970 (View on PubMed)

Other Identifiers

H-16019808

Identifier Type: -

Identifier Source: org_study_id