Efficacy and Complications of Microvascular Decompression

NCT04445766 | Completed DMC

• 1 other identifier: H-16019808
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

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

Conditions

Trigeminal Neuralgia

Keywords

neurosurgery

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Related Publications (1)

• 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.

  PMID: 36402970 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Dr Med Sci

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: May 1, 2012
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share