This study will be a single-centre, prospective, single-arm, open-label, 12-week pilot trial
assessing the safety and preliminary efficacy of a second MR-guided focused ultrasound
(MRgFUS) thalamotomy on the naïve brain hemisphere after 48 weeks or more of the first MRgFUS
thalamotomy in patients with medication-refractory ET.
This study will be conducted at the Focused Ultrasound Centre of Excellence at Sunnybrook
Health Sciences Centre/University of Toronto.
Patients who are medication-refractory for ET often require a surgical option to relieve
symptoms of ET and improve quality of life. To-date, unilateral MRgFUS has been beneficial in
providing patients with some of relief from tremor. However, tasks that require two hands
remain a challenge for many patients. Historical risks of bilateral treatment have been an
impediment to complete tremor relief. The introduction of MRI and current stereotactic
methodologies has significantly reduced the probability of non-target tissue injury. In this
study, a second MRgFUS thalamotomy will be performed in a cohort of patients who have already
successfully undergone unilateral MRgFUS treatment. Tremor severity, speech, balance, gait,
and cognition will be assessed during baseline and follow up visits.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.