NCT02624661

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

November 26, 2015

Last Update Submit

March 26, 2019

Conditions

Trigeminal NeuralgiaHeadache Disorders

Keywords

Trigeminal ganglionGlycerolNerve block

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of attacks with trigeminal neuralgia

    12 weeks

  • Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale

    12 weeks

  • Intensity of the trigeminal neuralgia attacks assessed by questionnaire

    12 weeks

  • Number of doses of common analgesics

    12 weeks

Study Arms (1)

Glycerol injection

EXPERIMENTAL

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

Drug: Glycerol

Interventions

GlycerolDRUG
Glycerol injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed and written consent
  • Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria
  • Unsatisfactory effect of pharmacological treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, Norway

Location

MeSH Terms

Conditions

Trigeminal NeuralgiaHeadache Disorders

Interventions

Glycerol

Condition Hierarchy (Ancestors)

Trigeminal Nerve DiseasesFacial NeuralgiaFacial Nerve DiseasesMouth DiseasesStomatognathic DiseasesCranial Nerve DiseasesNervous System DiseasesBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Erling A Tronvik, PhD, MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2015

First Posted

December 8, 2015

Study Start

May 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

NO(1)