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

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Terminated

CT.gov ID

NCT02624661

Collaborator

St. Olavs Hospital (Other)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trigeminal Neuralgia Headache Disorders	Drug: Glycerol	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glycerol injection The patients will be injected with glycerol using a new neuronavigation-based technique in the trigeminal ganglion.	Drug: Glycerol

Arm

Intervention/Treatment

Experimental: Glycerol injection

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

Drug: Glycerol

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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