Back to resultsGlycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique
Primary Purpose
Trigeminal Neuralgia, Headache Disorders
Status
Terminated
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Glycerol
Sponsored by
About this trial
This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring Trigeminal ganglion, Glycerol, Nerve block
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
Sites / Locations
- Department of Neuroscience, Norwegian University of Science and Technology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Glycerol injection
Arm Description
The patients will be injected with glycerol using a new neuronavigation-based technique in the trigeminal ganglion.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of attacks with trigeminal neuralgia
Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale
expressed as score on Visual analogue scale (VAS) for pain
Intensity of the trigeminal neuralgia attacks assessed by questionnaire
expressed by means of patient global impression of change questionnaire (PGIC)
Number of doses of common analgesics
week 1-4, week 5-8, week 9-12
Full Information
NCT ID
NCT02624661
First Posted
November 26, 2015
Last Updated
March 26, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02624661
Brief Title
Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique
Official Title
Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
technical problems
Study Start Date
May 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia, Headache Disorders
Keywords
Trigeminal ganglion, Glycerol, Nerve block
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glycerol injection
Arm Type
Experimental
Arm Description
The patients will be injected with glycerol using a new neuronavigation-based technique in the trigeminal ganglion.
Intervention Type
Drug
Intervention Name(s)
Glycerol
Primary Outcome Measure Information:
Title
Number of adverse events
Description
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.
Time Frame
For the follow-up period of 12 weeks
Secondary Outcome Measure Information:
Title
Number of attacks with trigeminal neuralgia
Time Frame
12 weeks
Title
Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale
Description
expressed as score on Visual analogue scale (VAS) for pain
Time Frame
12 weeks
Title
Intensity of the trigeminal neuralgia attacks assessed by questionnaire
Description
expressed by means of patient global impression of change questionnaire (PGIC)
Time Frame
12 weeks
Title
Number of doses of common analgesics
Description
week 1-4, week 5-8, week 9-12
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erling A Tronvik, PhD, MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neuroscience, Norwegian University of Science and Technology
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique
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