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出境医 / 临床实验 / Comparing Clinical Benefits of Gamma Knife and Microvascular Decompression for Trigeminal Neuralgia

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

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

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Radiation: Gamma knife Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Primary Trigeminal Neuralgia: A Comparative Study of Microvascular Decompression and Stereotactic Gamma Knife Radiosurgery
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2019
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Gamma knife group
Patients selected to be treated with gamma knife radiosurgery
 Radiation: Gamma knife
Microvascular decompression
Other Name: Surgery
Active Comparator: MVD Group
Patients treated with microvascular decompression
 Radiation: Gamma knife
Microvascular decompression
Other Name: Surgery
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary idiopathic trigeminal neuralgia

Exclusion Criteria:

  • secondary trigeminal neuralgia
Contacts and Locations

Sponsors and Collaborators
University of Baghdad
Investigators
Layout table for investigator information
Principal Investigator: Moneer K. Faraj, Facs Neurosciences hospital
Tracking Information
First Submitted Date  ICMJE June 15, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE January 1, 2016
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Clinical Benefits of Gamma Knife and Microvascular Decompression for Trigeminal Neuralgia
Official Title  ICMJE Treatment of Primary Trigeminal Neuralgia: A Comparative Study of Microvascular Decompression and Stereotactic Gamma Knife Radiosurgery
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Trigeminal Neuralgia
Intervention  ICMJE Radiation: Gamma knife
Microvascular decompression
Other Name: Surgery
Study Arms  ICMJE
  • Active Comparator: Gamma knife group
    Patients selected to be treated with gamma knife radiosurgery
    Intervention: Radiation: Gamma knife
  • Active Comparator: MVD Group
    Patients treated with microvascular decompression
    Intervention: Radiation: Gamma knife
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2019) 		84
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2019
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • primary idiopathic trigeminal neuralgia

Exclusion Criteria:

  • secondary trigeminal neuralgia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991039
Other Study ID Numbers  ICMJE Neurosciences-iraq
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Moneer k. Faraj, University of Baghdad
Study Sponsor  ICMJE University of Baghdad
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Moneer K. Faraj, Facs Neurosciences hospital
PRS Account University of Baghdad
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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