Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
Status:
Completed
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
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 surgery. There are
different types of procedures and most of them are complex with a risk for complications. The
researchers want to start a pilot study on 10 patients with a new surgical technique using
neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an
important role in facial pain. There have been a few trials trying to block this structure in
trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers
technique requires local anesthesia only (awake patient). The researchers believe that this
treatment can become a "low threshold"-treatment for patients who do not have enough effect
with pharmacological treatment and a better alternative to other complex surgical approaches.
Using this new neuronavigation system the researchers can reach this neural structure with
high precision.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Norwegian University of Science and Technology
Collaborator:
St. Olavs Hospital
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA