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

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ClinicalTrials.gov Identifier: NCT02624661
Recruitment Status : Recruiting
First Posted : December 8, 2015
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated Enrollment : 10 participants
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 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Glycerin
U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: 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 :
  1. Number of attacks with trigeminal neuralgia [ Time Frame: 12 weeks ]
  2. Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale [ Time Frame: 12 weeks ]
    expressed as score on Visual analogue scale (VAS) for pain

  3. Intensity of the trigeminal neuralgia attacks assessed by questionnaire [ Time Frame: 12 weeks ]
    expressed by means of patient global impression of change questionnaire (PGIC)

  4. Number of doses of common analgesics [ Time Frame: 12 weeks ]
    week 1-4, week 5-8, week 9-12


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624661


Contacts
Contact: Erling A Tronvik, PhD, MD erling.tronvik@ntnu.no
Contact: Daniel F Bratbak, MD daniel.f.bratbak@ntnu.no

Locations
Norway
Department of Neuroscience, Norwegian University of Science and Technology Recruiting
Trondheim, Norway
Contact: Erling A Tronvik, PhD, MD       erling.tronvik@ntnu.no   
Contact: Daniel F Bratbak, MD       daniel.f.bratbak@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Erling A Tronvik, PhD, MD Norwegian University of Science and Technology
More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02624661     History of Changes
Other Study ID Numbers: 2015/1192
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Trigeminal ganglion
Glycerol
Nerve block

Additional relevant MeSH terms:
Headache
Neuralgia
Ganglion Cysts
Trigeminal Neuralgia
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Brain Diseases
Central Nervous System Diseases
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs