Back to resultsComparing Clinical Benefits of Gamma Knife and Microvascular Decompression for Trigeminal Neuralgia
Primary Purpose
Trigeminal Neuralgia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gamma knife
Sponsored by
About this trial
This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring Trigeminal neuralgia, treatment
Eligibility Criteria
Inclusion Criteria:
- primary idiopathic trigeminal neuralgia
Exclusion Criteria:
- secondary trigeminal neuralgia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Gamma knife group
MVD Group
Arm Description
Patients selected to be treated with gamma knife radiosurgery
Patients treated with microvascular decompression
Outcomes
Primary Outcome Measures
Barrow Neurological Institute Pain Intensity scale (1-5)
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)
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)
Assess pain severity as impact to functional activities, the 7 is normal live activity and the worst is 1. It is dependent score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03991039
Brief Title
Comparing Clinical Benefits of Gamma Knife and Microvascular Decompression for Trigeminal Neuralgia
Official Title
Treatment of Primary Trigeminal Neuralgia: A Comparative Study of Microvascular Decompression and Stereotactic Gamma Knife Radiosurgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical randomized study to compare the clinical effectiveness between two modalities of treatment of trigeminal neuralgia namely gamma knife radio surgery and microvascular decompression
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia
Keywords
Trigeminal neuralgia, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gamma knife group
Arm Type
Active Comparator
Arm Description
Patients selected to be treated with gamma knife radiosurgery
Arm Title
MVD Group
Arm Type
Active Comparator
Arm Description
Patients treated with microvascular decompression
Intervention Type
Radiation
Intervention Name(s)
Gamma knife
Other Intervention Name(s)
Surgery
Intervention Description
Microvascular decompression
Primary Outcome Measure Information:
Title
Barrow Neurological Institute Pain Intensity scale (1-5)
Description
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
Time Frame
Two years
Title
visual analog scale (0-10)
Description
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
Time Frame
Two years
Title
Brief Pain Inventory (1-7)
Description
Assess pain severity as impact to functional activities, the 7 is normal live activity and the worst is 1. It is dependent score
Time Frame
ُTwo years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary idiopathic trigeminal neuralgia
Exclusion Criteria:
secondary trigeminal neuralgia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moneer K. Faraj, Facs
Organizational Affiliation
Neurosciences hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing Clinical Benefits of Gamma Knife and Microvascular Decompression for Trigeminal Neuralgia
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