NCT06821906

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
RADIATION	Stereotactic Radiosurgery	Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy
RADIATION	Stereotactic Radiosurgery	Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 130 Gy

Timeline

• Start date: 2024-12-16
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: Poland