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RecruitingNCT06821906EASIERUpdated Oct 20, 2026

Stereotactic Radiosurgery in the Treatment of Essential Tremor

A Phase 2 interventional study of Stereotactic Radiosurgery and Stereotactic Radiosurgery in Essential Tremor, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Recruiting at 1 site in Poland. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Essential Tremor

Keywords

  • tremor
  • stereotactic radiosurgery
  • frameless radiosurgery
  • essenstial tremor
  • CyberKnife
03

In context

Essential Tremor

272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.

This study's planned enrollment of 42 is above the median of 25 across 189 interventional studies indexed under Essential Tremor.

Browse Essential Tremor studies →

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 64 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Age under 50
  • Pregnancy
  • Duration of the disease less than 5 years
  • Dementia, psychosis or other condition that prevents giving 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 to magnetic resonance imaging
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Active comparator
    A

    Patients irradiated with the CyberKnife with a dose of 130 Gy

    Radiation: Stereotactic Radiosurgery

  • Experimental
    B

    Patients irradiated with the CyberKnife with a dose of 80 Gy

    Radiation: Stereotactic Radiosurgery

Interventions

  • RadiationStereotactic Radiosurgery

    Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy

  • RadiationStereotactic Radiosurgery

    Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 130 Gy

06

What researchers measure

Primary outcomes

  1. Treatment Efficacy

    Efficacy of radiosurgery treatment in patients with essential tremor assessed on a dedicated tremor severity scale - Fahn-Tolosa-Marin (FTM)

    Time frame: 24 months

Secondary outcomes

  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

    Time frame: 24 months

  2. Safety

    Safety and possible complications of radiosurgery assesed in Common Terminology Criteria for Adverse Events (CTCAE) v5.0

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗
  • 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. PubMed 21336920 ↗
  • 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. PubMed 36830825 ↗
  • 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. PubMed 18406912 ↗
  • Luo G, Neimat JS, Cmelak A, Kirschner AN, Attia A, Morales-Paliza M, Ding GX. Margin of error for a frameless image guided radiosurgery system: Direct confirmation based on posttreatment MRI scans. Pract Radiat Oncol. 2017 May-Jun;7(3):e223-e231. doi: 10.1016/j.prro.2016.08.006. Epub 2016 Aug 20. PubMed 27720703 ↗
  • Yu C, Main W, Taylor D, Kuduvalli G, Apuzzo ML, Adler JR Jr. An anthropomorphic phantom study of the accuracy of Cyberknife spinal radiosurgery. Neurosurgery. 2004 Nov;55(5):1138-49. doi: 10.1227/01.neu.0000141080.54647.11. PubMed 15509320 ↗
  • Campbell AM, Glover J, Chiang VL, Gerrard J, Yu JB. Gamma knife stereotactic radiosurgical thalamotomy for intractable tremor: a systematic review of the literature. Radiother Oncol. 2015 Mar;114(3):296-301. doi: 10.1016/j.radonc.2015.01.013. Epub 2015 Feb 14. PubMed 25690750 ↗
  • Hashim M, Vincken T, Kroi F, Gebregergish S, Spencer M, Wang J, Kampfenkel T, Lam A, He J. A systematic review of noninferiority margins in oncology clinical trials. J Comp Eff Res. 2021 Apr;10(6):443-455. doi: 10.2217/cer-2020-0200. Epub 2021 Mar 17. PubMed 33728935 ↗
  • Palesch YY. Some common misperceptions about P values. Stroke. 2014 Dec;45(12):e244-6. doi: 10.1161/STROKEAHA.114.006138. Epub 2014 Nov 6. No abstract available. PubMed 25378423 ↗
  • Chow S-C., Shao J., Wang H., Lokhnygina Y. Sample Size Calculations in Clinical Research. Third ed: Chapman and Hall/CRC; 2017.

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for May 2030, 64 months after the start.

Of 20 phase 2 interventional studies under Essential Tremor, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 29. This study's planned 64 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2025
First posted
Feb 12, 2025
StartActual
Dec 16, 2024
Primary completionEst.
May 1, 2030
CompletionEst.
May 2030
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: index terms, identifiers, verification date, oversight details and references
1 update, last Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Minor edits only
    + 5 other changes: index terms, identifiers, verification date, oversight details and references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06821906
Lead sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Responsible party
Sponsor
First posted
Feb 12, 2025
Start date
Dec 16, 2024
Primary completion
May 1, 2030 (estimated)
Completion
May 2030 (estimated)
Last update
Oct 20, 2026

Study contacts

Aleksandra Napieralska
Contact
aleksandra.napieralska@gliwice.nio.gov.pl
48322788056
Agnieszka Szczyrba
Contact
agnieszka.szczyrba@gliwice.nio.gov.pl
48322788001
Aleksandra Napieralska
principal investigator · Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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