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Efficacy and Complications of Microvascular Decompression

Sponsor
Danish Headache Center (Other)
Overall Status
Completed
CT.gov ID
NCT04445766
Collaborator
(none)
115
Enrollment
102
Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    115 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Efficacy and Complications of Microvascular Decompression - a Prospective Systematic Study of 115 Trigeminal Neuralgia Patients
    Actual Study Start Date :
    May 1, 2012
    Actual Primary Completion Date :
    Oct 31, 2020
    Actual Study Completion Date :
    Oct 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Degree of pain relief 2 years after MVD [2 years]

      Barrow Neurological Institute pain intensity score (BNI)

    2. Degree of complication rate 2 years after MVD [2 years]

      The frequency of predefined major and minor complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Danish Headache Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lars Bendtsen, MD, PhD, Dr Med Sci, Danish Headache Center
    ClinicalTrials.gov Identifier:
    NCT04445766
    Other Study ID Numbers:
    • H-16019808
    First Posted:
    Jun 24, 2020
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lars Bendtsen, MD, PhD, Dr Med Sci, Danish Headache Center
    neurosurgery
    Additional relevant MeSH terms:
    Trigeminal Neuralgia
    Neuralgia

    Study Results

    No Results Posted as of Apr 4, 2022