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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Tom
Gilbertson
+44 (0)1382 383617
t.gilbertson@dundee.ac.uk
Dr
Sarah
Inglis
+44 1382 383219
m.band@dundee.ac.uk
Parkinson's disease
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Parkinson's disease is a progressive neurodegenerative disease characterised by gradually worsening tremor, muscle rigidity and difficulties with starting and stopping movements. The tremor in Parkinson's disease occurs at rest and becomes less prominent with voluntary movement. It typically occurs first in the distal upper extremities then moves proximally and spreads to affect other parts of the body over time. Treatment for Parkinson’s disease includes supportive therapies and medications such as levodopa, dopamine agonists and monoamine oxidase B inhibitors. Surgery may be considered in people whose condition has not responded adequately to the best medical therapy. Surgical treatments include deep brain stimulation (DBS) and radiofrequency thalamotomy. Transcranial Magnetic Resonance guided focused ultrasound (MRgFUS) is a technology which allows permanent modification of brain function and relief of symptoms including tremors. MRgFUS thalamotomy, where focused ultrasound is targeted at the Ventral intermediate nucleus (Vim) of the thalamus, has been adopted worldwide as a minimally invasive alternative to established techniques such as Deep Brain Stimulation (DBS) in patients with medication-resistant Essential Tremor (ET). Clinicians based at Ninewells Hospital performed the first MRgFUS thalamotomy in Scotland in June 2021 and are the second unit in the UK able to deliver this therapy. The therapeutic effect of MRgFUS relies upon the permanent lesioning of the Vim by thermal coagulation necrosis caused by ultrasound-induced heating of the nucleus. Effective lesioning requires a 3-hour awake procedure during which patients receive repeated high-intensity focused ultrasound (HIFU) treatments. The intensity of each treatment is gradually increased to achieve thermal heating of the treatment target region to >50°C at which permanent lesioning and tremor suppression is achieved. HIFU involves the delivery of short (10-20 seconds) continuous ultrasound at intensities (~150-200W) necessary to produce the thermal effects. The potential benefits of unilateral MRI-guided focused ultrasound thalamotomy are that it: is less invasive than the other existing procedures; results in a faster recovery time; and allows for testing of the effects of sub-lethal doses before ablation. However, unlike deep brain stimulation, it can only be done on 1 side.
MRI guided focused ultrasound (MRgFUS) thalamotomy is not currently a NICE recommended treatment for Parkinson’s Disease in the UK. The aim of this study is to demonstrate that this is a safe and efficient treatment.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Subjects with unstable cardiac status including:1.1. Unstable angina pectoris on medication1.2. Subjects with documented myocardial infarction within six months of protocol entry1.3. Significant congestive heart failure1.4. Subjects with unstable ventricular arrhythmias1.5. Subjects with atrial arrhythmias that are not rate-controlled2. Severe hypertension (diastolic BP > 100 on medication)3. Significant speech impairment that would prevent communication during the procedure.4. Unsteadiness when walking or turning and or instability on tandem walking during the formal examination.5. Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.6. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium).7. Patient with severely impaired renal function with estimated glomerular filtration rate <30 mL/min/1.73m2 (or per local standards should that be more restrictive) and/or who is on dialysis.8. History of abnormal bleeding and/or coagulopathy9. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or haemorrhage (e.g. Avastin) within one month of focused ultrasound procedure10. History of immunocompromise including those who are HIV positive.11. History of intracranial haemorrhage12. Cerebrovascular disease (multiple CVA or CVA within 6 months)13. Subjects with uncontrolled symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema).14. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.)15. Significant claustrophobia that cannot be managed with mild medication.16. Subjects are unable to communicate with the investigator and staff.17. Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination. These include multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer’s disease.18. Presence of significant cognitive impairment as determined with a score ≤ 85 on the ACE-R.19. Diagnosis of Dementia including Parkinson’s Disease Dementia (PDD). 20. Subjects with life-threatening systemic diseases that include and are not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc.21. Subjects with a history of seizures within the past year.22. Subjects with a history of psychosis will be excluded. Subjects with a history of self-harm/personality disorder, bipolar disorder, or moderately severe depressive illness will be excluded. For the purpose of this study, we consider moderately severe depressive illness to include any subject who:22.1. has an IDS-SR score > 26 22.2. is currently under the care of a psychiatrist23. Subjects with risk factors for intraoperative or postoperative bleeding: platelet count less than 100,000 per cubic millimetre, INR coagulation studies exceeding local institution laboratory standards, or a documented coagulopathy24. Subjects with brain tumours25. Any illness that in the investigator's opinion precludes participation in this study.26. Pregnancy or lactation.27. Legal incapacity or limited legal capacity.28. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia29. Subjects who have been administered botulinum toxins into the arm, neck, or face for 5 months prior to Baseline.30. Subjects who have an Overall Skull Density Ratio of 0.3 or less as calculated from the screening CT.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Sarah
Inglis
+44 1382 383219
m.band@dundee.ac.uk
Dr
Tom
Gilbertson
+44 (0)1382 383617
t.gilbertson@dundee.ac.uk
The study is sponsored by University of Dundee and funded by Insightec Ltd.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
