Stereotactic Radiosurgery in the Treatment of Essential Tremor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stereotactic Radiosurgery, Stereotactic Radiosurgery.
- Who it may be relevant to
- Registry conditions: Essential Tremor. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Stereotactic Radiosurgery in the Treatment of Tremor in Patients with Essential Tremor - a Randomized Phase II Study
Overview
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
Detailed description
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:
1. control arm: patients irradiated with the CyberKnife with a dose of 130 Gy 2. test arm: patients irradiated with the CyberKnife with a dose of 80 Gy
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.
Interventions
- Radiation Stereotactic Radiosurgery
Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy - Radiation Stereotactic Radiosurgery
Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 130 Gy
Primary outcome measures
- Treatment Efficacy [Time frame: 24 months]
Secondary outcome measures (2)
- Quality of life [Time frame: 24 months]
- Safety [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Essential tremor diagnosed, Parkinson's disease and other causes of tremor excluded.
- Insufficient tremor control despite the use of available pharmacotherapy methods.
- Disqualification from the Deeply Brain Stimualtion procedure/lack of consent to perform it on the side qualified for Stereotactic Radiosurgery
- Consent to participate in a clinical trial.
Exclusion criteria
- Age under 50
- Pregnancy
- Duration of the disease less than 5 years
- Dementia, psychosis or other condition that prevents giving informed consent to participate in the study
- Poor general condition, serious comorbidities
- Structural changes in the basal ganglia or major atrophic changes
- Previous radiotherapy to the brain covering the potential treatment area
- Medical contraindications to magnetic resonance imaging
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch — Gliwice
Publications
- 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. PMID 20175185
- 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 No PMID 29193359
- 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. PMID 27769649
- Lenka A, Pandey S. Essential Tremor: Five New Things. Neurol Clin Pract. 2022 Apr;12(2):183-186. doi: 10.1212/CPJ.0000000000001145. PMID 35747894
- 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. PMID 18334856
- 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. PMID 10853075
- Young RF, Shumway-Cook A, Vermeulen SS, Grimm P, Blasko J, Posewitz A, Burkhart WA, Goiney RC. Gamma knife radiosurgery as a lesioning technique in movement disorder surgery. J Neurosurg. 1998 Aug;89(2):183-93. doi: 10.3171/jns.1998.89.2.0183. PMID 9688111
- 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. PMID 19291984
Identifiers
NCT: NCT06821906 · EASIER