Stereotactic Radiosurgery in the Treatment of Essential Tremor

Phase 2

Recruiting

• Conditions: Essential Tremor

• Registration Number: NCT06821906
• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology

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

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.

Study Timeline

• Study Start: 2024-12-16
• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Primary Completion: 2030-05-01
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment Efficacy	24 months	Efficacy of radiosurgery treatment in patients with essential tremor assessed on a dedicated tremor severity scale - Fahn-Tolosa-Marin (FTM)

Secondary Outcome Measures

Name	Time	Method
Quality of life	24 months	The impact of treatment on the quality of life of patients based on the dedicated Quality of Life in Essential Tremor questionnaire
Safety	24 months	Safety and possible complications of radiosurgery assesed in Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Trial Locations

Locations (1)

Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch; 🇵🇱 Gliwice, Poland