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

June 17, 2019 updated by: Dr. Moneer k. Faraj, University of Baghdad

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary idiopathic trigeminal neuralgia

Exclusion Criteria:

  • secondary trigeminal neuralgia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gamma knife group
Patients selected to be treated with gamma knife radiosurgery
Radiation: Gamma knife
Microvascular decompression
Other Names:
  • Surgery
Active Comparator: MVD Group
Patients treated with microvascular decompression
Radiation: Gamma knife
Microvascular decompression
Other Names:
  • Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two years
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
Two years
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
ُTwo years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Investigators

  • Principal Investigator: Moneer K. Faraj, Facs, Neurosciences hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

June 15, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neurosciences-iraq

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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