RecruitingPhase 2NCT06821906

Stereotactic Radiosurgery in the Treatment of Essential Tremor

Stereotactic Radiosurgery in the Treatment of Tremor in Patients with Essential Tremor - a Randomized Phase II Study

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Enrollment

42 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

Essential Tremor

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

Eligibility

Min Age: 50 Years

Inclusion Criteria4

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 Criteria8

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

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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

Locations(1)

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

Gliwice, Poland

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NCT06821906

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