Stereotactic Radiosurgery in the Treatment of Essential Tremor

Phase 2RecruitingNCT06821906

Maria Sklodowska-Curie National Research Institute of Oncology42 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Essential Tremor

Interventions

Stereotactic RadiosurgeryRADIATION

Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy

Stereotactic RadiosurgeryRADIATION

Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 130 Gy

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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: * 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

Locations (1)

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

Gliwice, Poland

RECRUITING

Outcomes

Primary Outcomes

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

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

Safety

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

Time frame: 24 months

Central Contacts

Aleksandra Napieralska

CONTACT

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

Agnieszka Szczyrba

CONTACT

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

Data from ClinicalTrials.gov

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