Trigeminal Neuralgia Clinical Trial
Official title:
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
Verified date | July 2019 |
Source | Norwegian University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 1, 2018 |
Est. primary completion date | November 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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, botulinum toxin type A, Botox or any of it's constituents or any other related medication - Treatment with medication that can interact with botulinum toxin type A |
Country | Name | City | State |
---|---|---|---|
Norway | Department of Neuroscience, Norwegian University of Science and Technology | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | St. Olavs Hospital |
Norway,
Crespi J, Bratbak D, Dodick DW, Matharu M, Jamtøy KA, Tronvik E. Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia. Headache. 2019 Jul 25. doi: 10.1111/head.13608. [Epub a — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Number of attacks with trigeminal neuralgia | 12 weeks | ||
Secondary | Intensity of the attacks | expressed as score on Visual analogue scale (VAS) for pain | 12 weeks | |
Secondary | Number of attacks with trigeminal neuralgia per 4 weeks per patient | 12 weeks | ||
Secondary | Number of doses of analgesics per 4 weeks per patient | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05152368 -
Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Trigeminal Neuralgia and Peripheral Neuropathy
|
Phase 1 | |
Recruiting |
NCT02801630 -
An Evaluation of the Effect of a Surface Acoustic Wave Patch Device on the Symptons of Trigeminal Neuralgia
|
N/A | |
Completed |
NCT02473016 -
Nasal Carbon Dioxide for the Symptomatic Treatment of Classical Trigeminal Neuralgia
|
Phase 2 | |
Recruiting |
NCT01364259 -
A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia
|
Phase 3 | |
Completed |
NCT01364272 -
Diffusion Tensor Imaging Magnetic Resonance Imaging (DTI MRI) as a Correlate to Pain Relief and Facial Numbness in Patients Following Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia
|
||
Completed |
NCT00603694 -
Hippocampal Radiation Exposure and Memory
|
N/A | |
Completed |
NCT00913107 -
Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia
|
Phase 2/Phase 3 | |
Recruiting |
NCT04996199 -
Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Trial
|
Phase 4 | |
Completed |
NCT06240494 -
Predictive Factors in Maxillary and Mandibular Nerve Radiofrequency Treatment for Trigeminal Neuralgia
|
||
Completed |
NCT05712993 -
Comparative Study Between Transcoronoid and Infrazygomatic Anterior Maneuvers
|
N/A | |
Completed |
NCT04371575 -
Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - a Prospective Study in 60 Patients
|
||
Completed |
NCT03669744 -
Regional Anesthesia in Refractory Trigeminal Neuralgia: 21 Cases Reported to the Limoges University Hospital
|
||
Completed |
NCT05032573 -
Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia
|
N/A | |
Recruiting |
NCT05615714 -
Paresthesia-free Peripheral Nerve Field Stimulation for Trigeminal Neuralgia (FreeST Trial)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04054024 -
Efficacy and Tolerability of Erenumab in Patients With Trigeminal Neuralgia
|
Phase 2 | |
Not yet recruiting |
NCT05451251 -
Deep Brain Stimulation for Refractory Trigeminal Neuralgia With a Demyelinating Pontine Lesion
|
N/A | |
Withdrawn |
NCT04353505 -
Intra-arterial Sphenopalatine Ganglion Block for Patients With Refractory Headache
|
Phase 1 | |
Withdrawn |
NCT01932255 -
CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap
|
N/A | |
Completed |
NCT05075707 -
Comparison Between Magnetic Field and Laser Therapy in Management of Trigeminal Neuralgia
|
N/A | |
Completed |
NCT06334796 -
Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology
|
Early Phase 1 |