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

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03991039
• Other study ID #: Neurosciences-iraq
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: June 2019
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 1, 2019
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• primary idiopathic trigeminal neuralgia

Exclusion Criteria:

• secondary trigeminal neuralgia

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Radiation:
• Gamma knife
Microvascular decompression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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