MR guided focused ultrasound treatment of Parkinson's disease
Research type
Research Study
Full title
A pivotal clinical trial of the management of the medically refractory dyskinesia symptoms or motor fluctuations of advanced idiopathic Parkinson's disease with unilateral lesioning of the globus pallidus using the Exablate neuro system.
IRAS ID
238482
Contact name
WMW GEDROYC
Contact email
Sponsor organisation
Insightec plc
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
This study examines the safety and effectiveness of transcranial focused ultrasound in the treatment of patients with drug resistant Parkinson's disease. Focused ultrasound will be used to interrupt electrical pathways in the brain in the globus pallidus to try to improve patient symptomatology. This site is a commonly used target in more interventional procedures such as deep brain stimulation which may be used in this context whereas focused ultrasound is a completely non-interventional technique which has a greatly reduced incidence of side effects in comparison to deep brain stimulation. Only patients with severe muscular problems such as slowness of movement and abnormal movements will be recruited. Patients with severe Parkinson's disease tremor will not be eligible for this particular study. Patients will be randomised to either the complete actual therapy or to a sham therapy procedure in which they receive no ultrasound energy. If patients who receive a sham procedure are still symptomatic at three months they will be able to receive the actual therapeutic procedure. All patients will be followed to 12 months to assess the safety and efficacy of this procedure utilising conventional well-established Parkinson's disease assessment criteria.
REC name
London - Stanmore Research Ethics Committee
REC reference
18/LO/0070
Date of REC Opinion
16 Apr 2018
REC opinion
Further Information Favourable Opinion