How common is the most common adult movement disorder? Update on the worldwide prevalence of essential tremor.
Elan D Louis, Joaquim J Ferreira
https://pubmed.ncbi.nlm.nih.gov/20175185Actively Recruiting
Phase 2
Age: 50Years +
All Genders
ID06821906
Stereotactic Radiosurgery for Essential Tremor Treatment Comparing 80 Gy and 130 Gy Doses - Randomized Phase II Study
Led by Maria Sklodowska-Curie National Research Institute of Oncology · Updated on 2025-02-12
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of stereotactic radiosurgery for treating essential tremor in adults who have not achieved sufficient tremor control with medications. The study focuses on patients over 50 years old with a disease duration longer than 5 years, who cannot or do not want to undergo Deep Brain Stimulation. This randomized Phase II study aims to compare different radiation doses to determine the best approach for managing essential tremor and to assess the impact on patients' quality of life and safety. Participants will be randomly assigned to one of two groups receiving frameless stereotactic radiosurgery using the CyberKnife device. One group will receive a radiation dose of 130 Gy, while the other group will receive 80 Gy. Both treatments are delivered non-invasively with the goal of reducing tremor symptoms. The study will last for 24 months, during which patients will be monitored for treatment outcomes and any side effects. During the study, participants will undergo regular assessments to evaluate treatment effectiveness, quality of life, and safety over a two-year period. Researchers will collect data on tremor control and monitor for any complications or adverse events related to the radiosurgery. Patients will provide informed consent before enrollment and will be followed closely throughout the study to ensure comprehensive evaluation of the treatments' impact.
CONDITIONS
Brief Title
Stereotactic Radiosurgery in the Treatment of Essential Tremor
Who Can Participate
Age: 50Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with essential tremor, excluding Parkinson's disease and other tremor causes
- Insufficient tremor control despite available medications
- Disqualified from or do not consent to Deep Brain Stimulation on the side planned for radiosurgery
- Age 50 years or older
- Disease duration longer than 5 years
- Consent to participate in the clinical trial
You will not qualify if you...
- Age under 50 years
- Pregnancy
- Disease duration less than 5 years
- Dementia, psychosis, or other conditions preventing informed consent
- Poor general health or serious other illnesses
- Structural brain changes in basal ganglia or major atrophy
- Previous brain radiotherapy covering treatment area
- Medical contraindications to MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment session
Participants receive frameless stereotactic radiosurgery with either 80 Gy or 130 Gy dose using the CyberKnife system.
1 visit (in-person)
Follow-up
Duration - Up to 24 months
Participants are monitored for treatment efficacy, quality of life, and safety for up to 24 months after radiosurgery.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
Gliwice, Poland, 44-101
Actively Recruiting
Loading map...
Research Team
A
Aleksandra Napieralska
A
Agnieszka Szczyrba
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society.
Kailash P Bhatia, Peter Bain, Nin Bajaj...
https://pubmed.ncbi.nlm.nih.gov/29193359Knowledge gaps and research recommendations for essential tremor.
Franziska Hopfner, Dietrich Haubenberger, Wendy R Galpern...
https://pubmed.ncbi.nlm.nih.gov/27769649Essential Tremor: Five New Things.
Abhishek Lenka, Sanjay Pandey
https://pubmed.ncbi.nlm.nih.gov/35747894Clinical cases where lesion therapy was chosen over deep brain stimulation.
Amanda K Hooper, Michael S Okun, Kelly D Foote...
https://pubmed.ncbi.nlm.nih.gov/18334856A comparison of surgical approaches for the management of tremor: radiofrequency thalamotomy, gamma knife thalamotomy and thalamic stimulation.
A Niranjan, A Jawahar, D Kondziolka...
https://pubmed.ncbi.nlm.nih.gov/10853075Gamma knife radiosurgery as a lesioning technique in movement disorder surgery.
R F Young, A Shumway-Cook, S S Vermeulen...
https://pubmed.ncbi.nlm.nih.gov/9688111Atlas-based functional radiosurgery: early results.
J Stancanello, P Romanelli, E Pantelis...
https://pubmed.ncbi.nlm.nih.gov/19291984Brain-focussed ultrasound: what's the "FUS" all about? A review of current and emerging neurological applications.
Laure Bretsztajn, Wladyslaw Gedroyc
https://pubmed.ncbi.nlm.nih.gov/29419328The stereotaxic method and radiosurgery of the brain.
L LEKSELL
https://pubmed.ncbi.nlm.nih.gov/14914373