Stereotactic Radiosurgery in the Treatment of Essential Tremor

NCT06821906 | Recruiting Phase 2

• 1 other identifier: EASIER
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Essential Tremor

Keywords

tremor; stereotactic radiosurgery; frameless radiosurgery; essenstial tremor; CyberKnife

Outcome Measures

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)

  24 months

Secondary Outcomes (2)

• Quality of life

  24 months

• Safety

  24 months

Study Arms (2)

A

ACTIVE COMPARATOR

Patients irradiated with the CyberKnife with a dose of 130 Gy

Radiation: Stereotactic Radiosurgery

B

EXPERIMENTAL

Patients irradiated with the CyberKnife with a dose of 80 Gy

Radiation: Stereotactic Radiosurgery

Interventions

Stereotactic Radiosurgery RADIATION

Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy

B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

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

Gliwice, 44-101, Poland

RECRUITING

Related Publications (24)

• 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 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.

  PMID: 29193359 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.

  PMID: 27769649 BACKGROUND

• Jackson AL, Murphy LL. Role of the hypothalamic-pituitary-adrenal axis in the suppression of luteinizing hormone release by delta-9-tetrahydrocannabinol. Neuroendocrinology. 1997 Jun;65(6):446-52. doi: 10.1159/000127208.

  PMID: 9208407 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.

  PMID: 18334856 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.

  PMID: 10853075 BACKGROUND

• 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 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.

  PMID: 19291984 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.

  PMID: 29419328 BACKGROUND

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

  PMID: 14914373 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.

  PMID: 1725560 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.

  PMID: 29473775 BACKGROUND

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

  PMID: 17317994 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.

  PMID: 34454047 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.

  PMID: 28298033 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.

  PMID: 21336920 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.

  PMID: 36830825 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.

  PMID: 18406912 BACKGROUND

• 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.

  PMID: 27720703 BACKGROUND

• 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.

  PMID: 15509320 BACKGROUND

• 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.

  PMID: 25690750 BACKGROUND

• 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.

  PMID: 33728935 BACKGROUND

• 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.

  PMID: 25378423 BACKGROUND

• Chow S-C., Shao J., Wang H., Lokhnygina Y. Sample Size Calculations in Clinical Research. Third ed: Chapman and Hall/CRC; 2017.

  BACKGROUND

MeSH Terms

Conditions

Essential Tremor; Tremor

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Aleksandra Napieralska

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Napieralska

CONTACT

48322788056; aleksandra.napieralska@gliwice.nio.gov.pl

Agnieszka Szczyrba

CONTACT

48322788001; agnieszka.szczyrba@gliwice.nio.gov.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, open label, interventional research experiment

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: December 16, 2024
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)