RAD 1601: EDGE Radiosurgery for Intractable Essential Tremor and Tremor-Dominant Parkinson's Disease

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Oct 4, 2017

Keywords

ClinConnect Summary

The RAD 1601 clinical trial is studying a new treatment method called frameless Virtual Cone Radiosurgical Thalamotomy, aimed at helping patients with persistent tremors caused by Essential Tremor or Tremor-Dominant Parkinson's Disease. This trial is specifically for patients who have not responded to other treatments and are not suitable candidates for a procedure known as deep brain stimulation (DBS). The effectiveness of this new approach will be measured using a tremor rating scale.

To participate in this trial, individuals must be at least 18 years old and have a specific type of tremor that hasn't improved with standard treatments. They should also have a good overall health status, meaning they are able to carry out everyday activities. However, those who have previously undergone brain radiation treatments or cannot have MRI scans due to medical reasons are not eligible. Participants will be closely monitored throughout the trial to evaluate the safety and effectiveness of the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with medical refractory essential tremor or tremor-dominant Parkinson's disease that are not candidates for deep brain stimulation (DBS), either by medical/surgical co-morbidities or by choice.
• • Patients must have an ECOG status of 0, 1, or 2.
• • Patients must be at least 18 years of age.
• • All patients must be given written informed consent.
• Exclusion Criteria:
• • Patients who have had prior radiosurgery or therapeutic brain radiation therapy.
• • Patients with medical contra-indications to MRI imaging (e.g. pacemaker).