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

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02624661
• Other study ID #: 2015/1192
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 2016
• Est. completion date: January 2019

Study information

• Verified date: March 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ganglion Cysts
• Headache
• Headache Disorders
• Neuralgia
• Trigeminal Neuralgia

Intervention

Drug:
• Glycerol

Locations

Country	Name	City	State
Norway	Department of Neuroscience, Norwegian University of Science and Technology	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	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.	For the follow-up period of 12 weeks
Secondary	Number of attacks with trigeminal neuralgia		12 weeks
Secondary	Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale	expressed as score on Visual analogue scale (VAS) for pain	12 weeks
Secondary	Intensity of the trigeminal neuralgia attacks assessed by questionnaire	expressed by means of patient global impression of change questionnaire (PGIC)	12 weeks
Secondary	Number of doses of common analgesics	week 1-4, week 5-8, week 9-12	12 weeks