Parkinson's disease Nervous System Diseases
Conditions
Interventions
This is a pilot study designed initially to treat 10 patients with Parkinson's disease in Scotland who have medication-resistant tremor. Patients will be identified by their clinical teams in Health B
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Age
30 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Men and women age 30 years or older. 2. Subjects who are able and willing to give consent and are able to attend all study visits. 3. An established diagnosis of Parkinson’s Disease as confirmed from clinical history based upon UK Brain Bank criteria. 4. Tremor refractory to adequate trials of at least two medications, including levodopa equivalent dosage of 800 mg (total daily dose). An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated. 5. Tremor dominant PD defined by the UPDRS tremor scores (items 16,20,21) to the mean UPDRS postural instability/gait disorder scores (items 13-15,29,30) was = 1.5 6. Vim nucleus of the thalamus can be targeted by the MRgFUS device. The thalamic region must be apparent on MRI such that targeting can be performed by measurement from a line connecting the anterior and posterior commissures of the brain. 7. Able to communicate sensations during the treatment. 8. Postural or resting tremor severity score of grade 3 or 4 in the most affected hand/arm as measured by the CRST (part A) rating scale while stable on medication (items 1-9). 9. Significant disability due to Parkinson’s tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities])
Exclusion criteria
Exclusion criteria: 1. Subjects with unstable cardiac status including: 1.1. Unstable angina pectoris on medication 1.2. Subjects with documented myocardial infarction within six months of protocol entry 1.3. Significant congestive heart failure 1.4. Subjects with unstable ventricular arrhythmias 1.5. Subjects with atrial arrhythmias that are not rate-controlled 2. 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 26 22.2. is currently under the care of a psychiatrist 23. 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 coagulopathy 24. Subjects with brain tumours 25. 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 o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tremor measured using the Clinical Rating Scale for Tremor (CRST) during MRgFUS treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The following Secondary outcome measures are assessed on Day 1 and 6 months post-treatment: 1. Tremor measured using the Clinical Rating Scale for Tremor (CRST) 2. Symptoms associated with Parkinson’s disease measured using the Unified Parkinson's Disease Rating Scale (UPDRS) 3. Quality of life measured using the Parkinson's Disease Questionnaire (PDQ-39) 4. Adverse events will be recorded based on reported incidents in the participant’s medical notes at Visit 3 (24 hours after procedure) and Visit 4 (6 months after procedure) 5. Medication collection, and changes to medication, will be recorded in the patients medical notes at Visits 3 and 4. | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactSarah Inglis
Outcome results
None listed