SUNRISE
Research type
Research Study
Full title
Pilot study of Safety and efficacy of Unilateral MR guided Focused Ultrasound thalamotomy in Tremor Dominant Parkinson’s Disease
IRAS ID
311871
Contact name
Tom Gilbertson
Contact email
Sponsor organisation
University of Dundee
ISRCTN Number
ISRCTN17281700
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
Around 145,000 people in the UK live with Parkinson’s Disease. The disease develops when cells in the brain stop working properly. This happens gradually and symptoms get worse over time. Symptoms include tremor, slowness of movement and stiffness. While medicines can help, for some people medicines do not prevent the tremor and this has a severe detrimental effect on their quality of life.
The aim of this study is to investigate the safety and effectiveness of a new treatment for tremor in Parkinson’s disease. This treatment is currently used to treat tremor caused by conditions other than Parkinson’s disease and is used to treat Parkinson’s disease tremor in other countries such as the US. The treatment is called MRI guided Focused Ultrasound (MRgFUS) thalamotomy. Ultrasound beams are guided by MRI (Magnetic Resonance Imaging) so that they target a region of the brain called the thalamus, which contains the brain circuits that cause tremor. Once the beams are targeted to the correct site in the brain, they heat the brain tissue and permanently destroy the brain cells that are causing the tremor.
The study is taking place at Ninewells Hospital, Dundee and involves 2 pre-treatment visits where patients’ suitability for thalamotomy treatment is assessed. The thalamotomy itself takes around 3 hours and is caried out while the patient is awake so any changes to the extent of the tremor can be assessed. Patients will then spend the night in the hospital under observation. Patients will return for assessments 6 months after treatment. A number of assessments including MRI scans of the brain will be carried out before and after treatment to determine the extent of any improvement to the patient’s tremor.REC name
South East Scotland REC 02
REC reference
23/SS/0038
Date of REC Opinion
18 Apr 2023
REC opinion
Further Information Favourable Opinion