NCT04801407

Brief Summary

This study aims to evaluate the results of percutaneous radiofrequency rhizotomy and the effectiveness of microvascular decompression for the treatment of trigeminal neuralgia and Comparing between them according the different outcome parameters.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

March 11, 2021

Last Update Submit

March 15, 2021

Conditions

Trigeminal Neuralgia

Keywords

trigeminal neuralgia

Outcome Measures

Primary Outcomes (1)

  • Barrow Neurological Institute Pain Intensity Score

    I (no pain, no medication), II (occasional pain, not requiring medication), III (some pain, controlled with medication), IV (some pain, not controlled with medication) V (severe pain, no pain relief with medication).

    3 months

Study Arms (2)

radiofrequency group

ACTIVE COMPARATOR

it is the group that will be treated with Percutaneous Radiofrequency Rhizotomy

Procedure: percutaneous radiofrequency trigeminal rhizotomy

Microvascular decompression group

ACTIVE COMPARATOR

it is the group that will be treated with Microvascular decompression

Procedure: Microvascular decompression of the trigeminal nerve

Interventions

percutaneous radiofrequency trigeminal rhizotomyPROCEDURE

percutaneous radiofrequency trigeminal rhizotomy is a perctaneous procedure that ablate the sensory part of the nerve and

radiofrequency group
Microvascular decompression of the trigeminal nervePROCEDURE

Microvascular decompression is a procedure that decompress the nerve from vascular conflict

Microvascular decompression group

Eligibility Criteria

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

You may qualify if:

  • Failed medical treatment more than 6 months

You may not qualify if:

  • Coagulation disorder or hemorrhagic disease;
  • Mental illness and inability to cooperate;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Abdelsamee Ahmed

Sohag, Sohag City, 82514, Egypt

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective case -series hospital based study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer neurosurgery department

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 17, 2021

Study Start

March 1, 2021

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

EG(1)