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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002643-33 | EudraCT Number |
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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin | Experimental | The patients will be injected with 25 IU of Botulinum Toxin Type A towards the sphenopalatine ganglion in the affected side (ipsilateral to the pain) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Number of adverse events. 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of attacks with trigeminal neuralgia | 12 weeks | |
| Intensity of the attacks | expressed as score on Visual analogue scale (VAS) for pain | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erling A Tronvik, PhD, MD | Norwegian University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neuroscience, Norwegian University of Science and Technology | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31342515 | Result | Crespi J, Bratbak D, Dodick DW, Matharu M, Jamtoy KA, Tronvik E. Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia. Headache. 2019 Sep;59(8):1229-1239. doi: 10.1111/head.13608. Epub 2019 Jul 25. |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| D020773 | Headache Disorders |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Number of attacks with trigeminal neuralgia per 4 weeks per patient | 12 weeks |
| Number of doses of analgesics per 4 weeks per patient | 12 weeks |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |