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The goal of this interventional study is to evaluate the effectiveness of treatment using stereotactic radiosurgery in the treatment of essential tremor in adult patients
The study will include patients diagnosed with essential tremor who have insufficient tremor control despite the use of available pharmacotherapy methods. The study will include patients who have been disqualified from the Deeply Brain Stimulation procedure or who do not consent to its performance. Additional conditions for the examination are age over 50 and the duration of the disease over 5 years.
After qualifying and giving written informed consent, the patient will be randomly assigned to one of two study arms:
The primary aim of the study is to determine the effectiveness of radiosurgery in patients with essential tremor. Secondary objectives will be to determine the impact of treatment on the quality of life of, as well as to assess the safety and possible complications of radiosurgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Patients irradiated with the CyberKnife with a dose of 130 Gy |
|
| B | Experimental | Patients irradiated with the CyberKnife with a dose of 80 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiosurgery | Radiation | Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Efficacy | Efficacy of radiosurgery treatment in patients with essential tremor assessed on a dedicated tremor severity scale - Fahn-Tolosa-Marin (FTM) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | The impact of treatment on the quality of life of patients based on the dedicated Quality of Life in Essential Tremor questionnaire | 24 months |
| Safety | Safety and possible complications of radiosurgery assesed in Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksandra Napieralska | Contact | 48322788056 | aleksandra.napieralska@gliwice.nio.gov.pl | |
| Agnieszka Szczyrba | Contact | 48322788001 | agnieszka.szczyrba@gliwice.nio.gov.pl |
| Name | Affiliation | Role |
|---|---|---|
| Aleksandra Napieralska | Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch | Recruiting | Gliwice | 44-101 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20175185 | Background | Louis ED, Ferreira JJ. How common is the most common adult movement disorder? Update on the worldwide prevalence of essential tremor. Mov Disord. 2010 Apr 15;25(5):534-41. doi: 10.1002/mds.22838. | |
| 29193359 | Background | Bhatia KP, Bain P, Bajaj N, Elble RJ, Hallett M, Louis ED, Raethjen J, Stamelou M, Testa CM, Deuschl G; Tremor Task Force of the International Parkinson and Movement Disorder Society. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018 Jan;33(1):75-87. doi: 10.1002/mds.27121. Epub 2017 Nov 30. |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D014202 | Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020820 | Dyskinesias |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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Randomised, open label, interventional research experiment
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| Stereotactic Radiosurgery | Radiation | Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 130 Gy |
|
| 24 months |
| 27769649 | Background | Hopfner F, Haubenberger D, Galpern WR, Gwinn K, Van't Veer A, White S, Bhatia K, Adler CH, Eidelberg D, Ondo W, Stebbins GT, Tanner CM, Helmich RC, Lenz FA, Sillitoe RV, Vaillancourt D, Vitek JL, Louis ED, Shill HA, Frosch MP, Foroud T, Kuhlenbaumer G, Singleton A, Testa CM, Hallett M, Elble R, Deuschl G. Knowledge gaps and research recommendations for essential tremor. Parkinsonism Relat Disord. 2016 Dec;33:27-35. doi: 10.1016/j.parkreldis.2016.10.002. Epub 2016 Oct 4. |
| 35747894 | Background | Lenka A, Pandey S. Essential Tremor: Five New Things. Neurol Clin Pract. 2022 Apr;12(2):183-186. doi: 10.1212/CPJ.0000000000001145. |
| 18334856 | Background | Hooper AK, Okun MS, Foote KD, Fernandez HH, Jacobson C, Zeilman P, Romrell J, Rodriguez RL. Clinical cases where lesion therapy was chosen over deep brain stimulation. Stereotact Funct Neurosurg. 2008;86(3):147-52. doi: 10.1159/000120426. Epub 2008 Mar 12. |
| 10853075 | Background | Niranjan A, Jawahar A, Kondziolka D, Lunsford LD. A comparison of surgical approaches for the management of tremor: radiofrequency thalamotomy, gamma knife thalamotomy and thalamic stimulation. Stereotact Funct Neurosurg. 1999;72(2-4):178-84. doi: 10.1159/000029723. |
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| 19291984 | Background | Stancanello J, Romanelli P, Pantelis E, Sebastiano F, Modugno N. Atlas-based functional radiosurgery: early results. Med Phys. 2009 Feb;36(2):457-63. doi: 10.1118/1.3056460. |
| 29419328 | Background | Bretsztajn L, Gedroyc W. Brain-focussed ultrasound: what's the "FUS" all about? A review of current and emerging neurological applications. Br J Radiol. 2018 Jul;91(1087):20170481. doi: 10.1259/bjr.20170481. Epub 2018 Mar 6. |
| 14914373 | Background | LEKSELL L. The stereotaxic method and radiosurgery of the brain. Acta Chir Scand. 1951 Dec 13;102(4):316-9. No abstract available. |
| 1725560 | Background | Lindquist C, Kihlstrom L, Hellstrand E. Functional neurosurgery--a future for the gamma knife? Stereotact Funct Neurosurg. 1991;57(1-2):72-81. doi: 10.1159/000099557. |
| 29473775 | Background | Martinez-Moreno NE, Sahgal A, De Salles A, Hayashi M, Levivier M, Ma L, Paddick I, Regis J, Ryu S, Slotman BJ, Martinez-Alvarez R. Stereotactic radiosurgery for tremor: systematic review. J Neurosurg. 2018 Feb 23;130(2):589-600. doi: 10.3171/2017.8.JNS17749. Print 2019 Feb 1. |
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| 34454047 | Background | Khattab MH, Cmelak AJ, Sherry AD, Luo G, Wang L, Yu H, Hedera P, Phibbs FT, Lindsell CJ, Neimat J, Kirschner AN. Noninvasive Thalamotomy for Refractory Tremor by Frameless Radiosurgery. Int J Radiat Oncol Biol Phys. 2022 Jan 1;112(1):121-130. doi: 10.1016/j.ijrobp.2021.08.021. Epub 2021 Aug 25. |
| 28298033 | Background | Kim W, Sharim J, Tenn S, Kaprealian T, Bordelon Y, Agazaryan N, Pouratian N. Diffusion tractography imaging-guided frameless linear accelerator stereotactic radiosurgical thalamotomy for tremor: case report. J Neurosurg. 2018 Jan;128(1):215-221. doi: 10.3171/2016.10.JNS161603. Epub 2017 Feb 24. |
| 21336920 | Background | Franzini A, Marchetti M, Brait L, Milanesi I, Messina G, Forapani E, Broggi G, Fariselli L. Deep brain stimulation and frameless stereotactic radiosurgery in the treatment of bilateral parkinsonian tremor: target selection and case report of two patients. Acta Neurochir (Wien). 2011 May;153(5):1069-75. doi: 10.1007/s00701-011-0962-0. Epub 2011 Feb 20. |
| 36830825 | Background | Goc B, Roch-Zniszczol A, Larysz D, Zarudzki L, Stapor-Fudzinska M, Rozek A, Wozniak G, Boczarska-Jedynak M, Miszczyk L, Napieralska A. The Effectiveness and Toxicity of Frameless CyberKnife Based Radiosurgery for Parkinson's Disease-Phase II Study. Biomedicines. 2023 Jan 20;11(2):288. doi: 10.3390/biomedicines11020288. |
| 18406912 | Background | Solberg TD, Medin PM, Mullins J, Li S. Quality assurance of immobilization and target localization systems for frameless stereotactic cranial and extracranial hypofractionated radiotherapy. Int J Radiat Oncol Biol Phys. 2008;71(1 Suppl):S131-5. doi: 10.1016/j.ijrobp.2007.05.097. |
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| Background | Chow S-C., Shao J., Wang H., Lokhnygina Y. Sample Size Calculations in Clinical Research. Third ed: Chapman and Hall/CRC; 2017. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |