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technical problems
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycerol injection | Experimental | The patients will be injected with glycerol using a new neuronavigation-based technique in the trigeminal ganglion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycerol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of attacks with trigeminal neuralgia | 12 weeks | |
| Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale | expressed as score on Visual analogue scale (VAS) for pain |
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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 |
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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 |
|---|---|
| D005990 | Glycerol |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 12 weeks |
| Intensity of the trigeminal neuralgia attacks assessed by questionnaire | expressed by means of patient global impression of change questionnaire (PGIC) | 12 weeks |
| Number of doses of common analgesics | week 1-4, week 5-8, week 9-12 | 12 weeks |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D002241 |
| Carbohydrates |