NCT03991039

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

June 15, 2019

Last Update Submit

June 17, 2019

Conditions

Trigeminal Neuralgia

Keywords

Trigeminal neuralgia, treatment

Outcome Measures

Primary Outcomes (3)

  • 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

    Two years

  • 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

    Two years

  • 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

    ُTwo years

Study Arms (2)

Gamma knife group

ACTIVE COMPARATOR

Patients selected to be treated with gamma knife radiosurgery

Radiation: Gamma knife

MVD Group

ACTIVE COMPARATOR

Patients treated with microvascular decompression

Radiation: Gamma knife

Interventions

Gamma knifeRADIATION

Microvascular decompression

Also known as: Surgery
Gamma knife groupMVD Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary idiopathic trigeminal neuralgia

You may not qualify if:

  • secondary trigeminal neuralgia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

RadiosurgerySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresInvestigative Techniques

Study Officials

  • Moneer K. Faraj, Facs

    Neurosciences hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant neurosurgeon

Study Record Dates

First Submitted

June 15, 2019

First Posted

June 19, 2019

Study Start

January 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

June 19, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share