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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Aleksandra Napieralska contact

48322788056

aleksandra.napieralska@gliwice.nio.gov.pl

Agnieszka Szczyrba contact

48322788001

agnieszka.szczyrba@gliwice.nio.gov.pl

Poland1 site, 1 recruiting

  • Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

    Gliwice, 44-101

    Aleksandra Napieralska, 48322788056, aleksandra.napieralska@gliwice.nio.gov.pl

    Recruiting

Other trials in Poland

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:

  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.

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 groups in NCT06821906
Study groupRoleWhat they receive
AActive comparatorPatients irradiated with the CyberKnife with a dose of 130 Gy
Receives: Radiation: Stereotactic Radiosurgery
BExperimentalPatients 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.

  1. 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)

  1. 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

  2. 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.

  1. First posted12 Feb 2025
  2. Study start16 Dec 2024
  3. Primary completion1 May 2030 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

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)
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 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 Nov 30.

    PubMed 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. 2016 Dec;33:27-35. doi: 10.1016/j.parkreldis.2016.10.002. Epub 2016 Oct 4.

    PubMed 27769649

  • Lenka A, Pandey S. Essential Tremor: Five New Things. Neurol Clin Pract. 2022 Apr;12(2):183-186. doi: 10.1212/CPJ.0000000000001145.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 19291984

  • 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.

    PubMed 29419328

  • LEKSELL L. The stereotaxic method and radiosurgery of the brain. Acta Chir Scand. 1951 Dec 13;102(4):316-9. No abstract available.

    PubMed 14914373

  • 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.

    PubMed 1725560

  • 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.

    PubMed 29473775

  • Duma CM. Movement disorder radiosurgery--planning, physics and complication avoidance. Prog Neurol Surg. 2007;20:249-266. doi: 10.1159/000100168.

    PubMed 17317994

  • 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.

    PubMed 34454047

  • 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.

    PubMed 28298033

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aleksandra Napieralska (48322788056, aleksandra.napieralska@gliwice.nio.gov.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Efficacy (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06821906, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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