A Study to Evaluate Temporary Blood Brain Barrier Disruption in Patients With Parkinson's Disease… (NCT03608553) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate Temporary Blood Brain Barrier Disruption in Patients With Parkinson's Disease Dementia
Spain20 participantsStarted 2018-11-26
Plain-language summary
The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and initial efficacy of this treatment (temporary disruption of the BBB) using this ExAblate Model 4000 Type 2 System in patients with mild to moderate Parkinson´s Disease Dementia
Who can participate
Age range60 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Parkinson´s Disease, according to the UK Parkinson´s Disease Society Brain Bank (Gelb et al. 1999)
✓. Parkinson´s Disease patients diagnosed with mild-moderate dementia according to the Movement Disorders Criteria (Emre et al. 2007)
âś“. Able and willing to give informed consent, or has delegated this to a substitute decision maker.
✓. Mini Mental State Exam (MMSE) scores ≥16 (able to complete a Neuropsychological evaluation)
✓. Geriatric Depression Scale (GDS) score of ≤ 20
âś“. Age: 60-80 years
âś“. Able to attend all study visits (i.e., life expectancy of 1 year).
Exclusion criteria
âś•. Clips or other metallic implanted objects in the skull or the brain, except shunts
âś•. Significant cardiac disease or unstable hemodynamic status
âś•. Uncontrolled hypertension (systolic \> 150 and diastolic BP \> 100 on medication)
âś•. Medications known to increase risk of hemorrhage, (e.g.: patients should be off of ASA for at least 7 days prior to treatment) or anticoagulants
âś•. History of a bleeding disorder
âś•. Significant depression and at potential risk of suicide
What they're measuring
1
Number of participants with treatment related Adverse Events as assessed by patient examination and MR imaging
Timeframe: Treatment through Day 14 after Second Treatment