Using stereotactic radiosurgery to treat essential tremor
Stereotactic Radiosurgery in the Treatment of Tremor in Patients with Essential Tremor - a Randomized Phase II Study
This study is testing whether a special type of radiation treatment can help adults over 50 with essential tremor who haven't found relief from medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology Academic / other |
| Locations | 1 site (Gliwice) |
| Trial ID | NCT06821906 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of stereotactic radiosurgery in adult patients diagnosed with essential tremor who have not achieved sufficient tremor control with pharmacotherapy. Participants will be randomly assigned to receive either a higher or lower dose of radiation using the CyberKnife system. The study will assess both the effectiveness of the treatment and its impact on patients' quality of life, while also monitoring for safety and potential complications. Eligible patients are those over 50 years old with a diagnosis of essential tremor lasting more than five years.
Who should consider this trial
Good fit: Ideal candidates are adults over 50 with essential tremor who have not responded to medication and are not suitable for deep brain stimulation.
Not a fit: Patients under 50, those with other causes of tremor, or those with serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve tremor control and quality of life for patients with essential tremor.
How similar studies have performed: While stereotactic radiosurgery is a well-established technique for other conditions, its application for essential tremor is still being explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gliwice
- Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch — Gliwice, Poland (Recruiting)
Study contacts
- Principal investigator: Aleksandra Napieralska — Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch
- Study coordinator: Aleksandra Napieralska
- Email: aleksandra.napieralska@gliwice.nio.gov.pl
- Phone: 48322788056
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.