Essential TremorPhase 2EASIERNCT06821906
Stereotactic Radiosurgery in the Treatment of Essential Tremor
A Phase 2 study testing Stereotactic Radiosurgery in people with Essential Tremor, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePoland
- Study dates
- 16 Dec 2024to May 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, 44-101
Aleksandra Napieralska, 48322788056, aleksandra.napieralska@gliwice.nio.gov.pl
About this study
Official title: Stereotactic Radiosurgery in the Treatment of Tremor in Patients With Essential Tremor - a Randomized Phase II Study
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
Read the 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:
- control arm: patients irradiated with the CyberKnife with a dose of 130 Gy
- 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.
- Conditions
- Essential Tremor
- Being tested
- Stereotactic Radiosurgery
- Keywords
- tremor, stereotactic radiosurgery, frameless radiosurgery, essenstial tremor, CyberKnife
- Medical subject headings
- Essential Tremor, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiosurgeryRadiation
Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy
Stereotactic RadiosurgeryRadiation
Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 130 Gy
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients irradiated with the CyberKnife with a dose of 130 Gy Receives: Radiation: Stereotactic Radiosurgery |
| B | Experimental | Patients irradiated with the CyberKnife with a dose of 80 Gy Receives: Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Efficacy
Efficacy of radiosurgery treatment in patients with essential tremor assessed on a dedicated tremor severity scale - Fahn-Tolosa-Marin (FTM)
Measured: 24 months
Secondary outcomes (2)
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
Measured: 24 months
Safety
Safety and possible complications of radiosurgery assesed in Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start16 Dec 2024
- Primary completion1 May 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, open label, interventional research experiment
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksandra Napieralska, Principal investigator, Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821906
- Sponsor's protocol ID
- EASIER
- Acronym
- EASIER
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20175185Bhatia 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.
PubMed 29193359Hopfner 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.
PubMed 27769649Lenka A, Pandey S. Essential Tremor: Five New Things. Neurol Clin Pract. 2022 Apr;12(2):183-186. doi: 10.1212/CPJ.0000000000001145.
PubMed 35747894Hooper 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.
PubMed 18334856Niranjan 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.
PubMed 10853075Young 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.
PubMed 9688111Stancanello 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.
PubMed 19291984Bretsztajn 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.
PubMed 29419328LEKSELL L. The stereotaxic method and radiosurgery of the brain. Acta Chir Scand. 1951 Dec 13;102(4):316-9. No abstract available.
PubMed 14914373Lindquist 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.
PubMed 1725560Martinez-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.
PubMed 29473775Duma CM. Movement disorder radiosurgery--planning, physics and complication avoidance. Prog Neurol Surg. 2007;20:249-266. doi: 10.1159/000100168.
PubMed 17317994Khattab 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.
PubMed 34454047Kim 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.
PubMed 28298033