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

N

Norwegian University of Science and Technology

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Headache Disorders
Trigeminal Neuralgia

Treatments

Drug: Glycerol

Study type

Interventional

Funder types

Other

Identifiers

NCT02624661
2015/1192

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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