Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique

NCT ID: NCT02624661

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-01-31

Brief Summary

Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered a type of surgery, which involves the injection of glycerol in a nerve structure called trigeminal ganglion. The researchers will do a pilot study on 10 patients with a new surgical technique using neuronavigation. The researchers believe that this new neuronavigation-based system can improve the precision of the technique and reduce the risk for complications.

Conditions

Trigeminal Neuralgia; Headache Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Glycerol injection

The patients will be injected with glycerol using a new neuronavigation-based technique in the trigeminal ganglion.

Group Type: EXPERIMENTAL

Glycerol

Intervention Type: DRUG

Interventions

Glycerol

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Informed and written consent
• Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria
• Unsatisfactory effect of pharmacological treatment

Exclusion Criteria

• Microvascular decompression is seen as a better alternative
• Heart or lung disease
• Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
• Psychiatric illness that hinders participation in the study
• Known pregnancy or breast feeding
• Inadequate use of contraceptives
• Overuse or abuse of opioids
• Abuse of medications, narcotics or alcohol
• Anomalies which hinder or impede the used method of injection
• Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erling A Tronvik, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, , Norway

Countries

Norway

Other Identifiers

2015/1192

Identifier Type: -

Identifier Source: org_study_id