PD012
Research type
Research Study
Full title
A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson’s Disease
IRAS ID
311870
Contact name
Tom Gilbertson
Contact email
Sponsor organisation
Insightec Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
clinicaltrials.gov, NCT04991831
Duration of Study in the UK
7 years, 0 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.
A related study (IRAS 311871) will evaluate the safety and efficacy of MRI-guided ultrasound thalamotomy as treatment for tremor in these patients. This current study will follow up those patients over a period of 5 years. They will have follow up appointments at 1,3 and 6 months, and annually for 5 years. Key assessments that will be collected at baseline (before thalamotomy) and at each follow up visit will include medication usage, and scoring of tremor using the clinical rating scale for tremor (CRST). The follow up data collected for these patients will be entered into a registry which will collect data, as well as adverse events for safety, from sites in the US and Europe. The overall target for recruitment to the study (total for all sites) is 50 patients.REC name
South East Scotland REC 02
REC reference
23/SS/0039
Date of REC Opinion
18 Apr 2023
REC opinion
Further Information Favourable Opinion