Treatment of Essential Tremor on Both Sides Using Gamma Knife Phase IIIII Trial for Patients Previously Treated on One Side

What this Trial Is About

Researchers are evaluating the use of Gamma Knife thalamotomy for patients with essential tremor who have already undergone successful treatment on one side of the brain. This combined Phase IIIII multicenter trial aims to study the effects and safety of treating the opposite side to improve quality of life. The trial will assess changes in tremor impact and patient health over time, with particular focus on side effects and functional outcomes. Participants will receive a contralateral thalamotomy using a frame-based Gamma Knife Perfexion or Icon system. The initial Phase II portion involves 10 patients, with plans to expand to Phase III by enrolling 40 more after safety review. Treatments target the VIM nucleus of the thalamus, and patients will be monitored at multiple intervals including 3, 6, 12, 24, and 36 months after the procedure. During the study, participants will undergo evaluations of tremor severity, gait, speech, and quality of life through filmed assessments and questionnaires. Safety monitoring includes grading side effects per established criteria. The primary outcomes focus on changes in quality of life QUEST score and patient-reported health utility at 12 months. Secondary outcomes include objective measures of tremor, gait, speech, adverse events, and long-term follow-up to 36 months after treatment.

Bilateral Essential Tremor Treatment With Gamma Knife