Comparing Clinical Benefits of Gamma Knife and Microvascular Decompression for Trigeminal Neuralgia

Clinical randomized study to compare the clinical effectiveness between two modalities of treatment of trigeminal neuralgia namely gamma knife radio surgery and microvascular decompression

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

A randomized prospective study conducted in The Neurosciences Hospital, Baghdad, from January 2016 to January 2018, patients had either GKR treatment or treated with MVD. The pain evaluated pre- and post-operatively using the Barrow Neurological Institute Pain Intensity scale (BNIPI), visual analog scale (VAS) and Brief Pain Inventory Facial (BPI-Facial) scoring systems. In GKR procedure, the trigeminal root entry zone targeted with a radiation dose of 80 Gy. MVD was performed using retro-sigmoid approach. Follow-up period for two years

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

primary idiopathic trigeminal neuralgia

Exclusion criteria

secondary trigeminal neuralgia

Treatment and study plan

Gamma knife

Radiation

Microvascular decompression

Other names: Surgery

Primary outcomes

Barrow Neurological Institute Pain Intensity scale (1-5)

Time frame: Two years

The pain evaluated pre- and post-operatively with the use of analgesic drugs the best is 1 indicates free of pain, the worst is 5. It is dependent score
visual analog scale (0-10)

Time frame: Two years

Pain severity described subjectively by the patient himself pre and post treatment , the 0 is free of pain and worst is 10. It is dependent score
Brief Pain Inventory (1-7)

Time frame: ُTwo years

Assess pain severity as impact to functional activities, the 7 is normal live activity and the worst is 1. It is dependent score

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

Treatment of Primary Trigeminal Neuralgia: A Comparative Study of Microvascular Decompression and Stereotactic Gamma Knife Radiosurgery

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2019
First posted: Jun 19, 2019
Registry last updated: Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed