Researchers at Imperial College Healthcare NHS Trust in London recently announced that they had completed treatment of the first patient in a clinical trial using staged bilateral focused ultrasound to treat medication-refractory essential tremor (ET).
In previous studies, patients were only offered treatment on one side of the brain, and most selected the side that controlled their dominant hand. The objective of this prospective, multisite, single-arm, open-label study is to determine the safety and efficacy of using Insightec’s Exablate Neuro device to treat both sides of the brain in patients with bilateral ET.
Researchers are performing a thalamotomy, and the specific target is the ventral intermediate nucleus (VIM) of the thalamus. The second focused ultrasound ablation procedure – on the other side of the study participant’s brain – is performed at least nine months after the first side is treated.
The first patient, who was originally treated one year earlier, was enrolled in the new study and received his second treatment in early February 2019.
“The first patient that we treated puts the clinical trial into context,” said Wladyslaw Gedroyc, MBBS, MRCP, FRCR, the trial’s Principal Investigator. “At 74-years-old, he said after his bilateral procedure that he felt a whole man now for the first time in 60 years.”
“Professor Gedryoc and his team have led several projects that have advanced the field of focused ultrasound,” said Foundation Chairman Neal F. Kassell, MD. “This study will be a significant addition if it eventually gives patients more treatment options. The improvement in quality of life is an important consideration for people who suffer from tremors.”
Eligible patients must have previously undergone Exablate thalamotomy for their essential tremor in a clinical study or in a commercial procedure at least nine months prior to enroll in this study to receive treatment on the contralateral side. Patients who would benefit from bilateral treatment for their ET and who are willing to undergo the procedure twice are also eligible to enroll.
ET is the most common movement disorder, affecting an estimated 3% of the population, or approximately 10 million individuals in the United States. ET is commonly viewed as a relatively benign disease, however, the associated disabling aspects of ET, such as significant tremor of the hands, can impair patients’ ability to eat, shave, write, perform household activities, and function in the workplace. The underlying etiology of ET is unclear, but cases often run in families (familial tremor). It has been estimated that approximately 50% of all cases are due to a genetic mutation, and the pattern of inheritance is most consistent with autosomal dominant transmission (i.e., dominant trait).
Information for Patients
This study is open only to UK residents. Patients who are interested in participating in this UK study should contact 020 331 10327 or firstname.lastname@example.org.
For additional information, please go to clinicaltrials.gov (NCT03465761).