Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, 44-101, Poland
Location status: Recruiting
NCT Number: NCT06821906
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
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Phase 2
Gliwice, 44-101, Poland
Location status: Recruiting
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Frameless Stereotactic Radiosurgery- CyberKnife with a dose of 80 Gy
Time frame: 24 months
Efficacy of radiosurgery treatment in patients with essential tremor assessed on a dedicated tremor severity scale - Fahn-Tolosa-Marin (FTM)
Time frame: 24 months
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 and possible complications of radiosurgery assesed in Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Contact information is provided by the study sponsor or research team.
Agnieszka Szczyrba
CONTACT
Aleksandra Napieralska
CONTACT
Maria Sklodowska-Curie National Research Institute of Oncology
Other
Stereotactic Radiosurgery in the Treatment of Tremor in Patients with Essential Tremor - a Randomized Phase II Study
Acronym: EASIER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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