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

Sponsor
University of Baghdad (Other)
Overall Status
Completed
CT.gov ID
NCT03991039
Collaborator
(none)
84
Enrollment
2
Arms
36
Actual Duration (Months)

Study Details

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
  • Radiation: Gamma knife
 N/A

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

Study Type:
Interventional
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 :
Jan 1, 2016
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Jan 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 Names:
  • Surgery

    		•
    Active Comparator: MVD Group

    Patients treated with microvascular decompression

    Radiation: Gamma knife
    Microvascular decompression
    Other Names:
  • Surgery

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Barrow Neurological Institute Pain Intensity scale (1-5) [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) [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) [ُ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

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • primary idiopathic trigeminal neuralgia
    Exclusion Criteria:
    • secondary trigeminal neuralgia

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Baghdad

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Moneer k. Faraj, Consultant neurosurgeon, University of Baghdad
    ClinicalTrials.gov Identifier:
    NCT03991039
    Other Study ID Numbers:
    • Neurosciences-iraq
    First Posted:
    Jun 19, 2019
    Last Update Posted:
    Jun 19, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr. Moneer k. Faraj, Consultant neurosurgeon, University of Baghdad
    Trigeminal neuralgia, treatment
    Additional relevant MeSH terms:
    Trigeminal Neuralgia
    Neuralgia

    Study Results

    No Results Posted as of Jun 19, 2019