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

Phase 1

Terminated

• Conditions: Trigeminal Neuralgia; Headache Disorders
• Interventions: Drug: Glycerol

• Registration Number: NCT02624661
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-26
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-08
• Study Start: 2016-05
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Glycerol injection	Glycerol	The patients will be injected with glycerol using a new neuronavigation-based technique in the trigeminal ganglion.

Primary Outcome Measures

Name	Time	Method
Number of adverse events	For the follow-up period of 12 weeks	Number of adverse events and number of participants with adverse events after glycerol injection in the trigeminal ganglion and severity of adverse events by the method used. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations.

Secondary Outcome Measures

Name	Time	Method
Number of attacks with trigeminal neuralgia	12 weeks
Intensity of the trigeminal neuralgia attacks assessed by questionnaire	12 weeks	expressed by means of patient global impression of change questionnaire (PGIC)
Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale	12 weeks	expressed as score on Visual analogue scale (VAS) for pain
Number of doses of common analgesics	12 weeks	week 1-4, week 5-8, week 9-12

Trial Locations

Locations (1)

Department of Neuroscience, Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway