A Study to Evaluate the Safety and Feasibility of Temporary Blood Brain Barrier Disruption Using MR Guided FUS in Patients With Parkinson's Disease Dementia
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|ClinicalTrials.gov Identifier: NCT03608553|
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinsons Disease With Dementia||Device: MR Guided Focused Ultrasound||Not Applicable|
This study is a prospective, single-arm, non-randomized, safety and feasibility trial of focal BBB disruption using the ExAblate® Model 4000 Type 2 (220 kHz) system with Luminity® ultrasound contrast in 10 patients with mild to moderate Parkinson's Disease Dementia. Patients, together with their caregivers, will be approached after their identification by a team of neurosurgeons and neurologists who specialize in the management of cognitive disorders and functional neurosurgery. The study will be discussed with them, and all patients, or their legal representatives will provide informed consent to participate in the study.
This first in human trial will be divided into two stages. In the first stage, patients will undergo small volume BBB disruption, establishing the minimum required sonication parameters to open the BBB, as evidenced by gadolinium enhancement on T1-weighted MRI. Stage I is defined as a discrete region of approximately 9 mm x 9 mm area in the right parietooccipitotemporal cortex. Multiple sonications will be performed starting at low energy and ramping up until the BBB is observed to open.
The subjects will then be removed from the ExAblate® Neuro device and followed for safety for 2 weeks. If the subject experienced BBB disruption without any serious adverse effects (such as brain edema), then the subject may proceed to Stage II where a larger volume (2.5-3.0 cm) will be targeted. Subjects will be followed for an additional 2 weeks for safety and preliminary effectiveness.
The staged approach will allow determination of:
- Safety of BBB disruption
- Feasibility of disruption the BBB
- Reversibility of BBB disruption
- Reproducibility of BBB disruption
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Evaluate the Safety and Feasibility of Temporary Blood Brain Barrier Disruption (BBBD) Using Exablate MR Guided Focused Ultrasound in Patients With Parkinson's Disease Dementia|
|Estimated Study Start Date :||October 7, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
|Experimental: Transcranial ExAblate MR Guided Focused Ultrasoun||
Device: MR Guided Focused Ultrasound
Blood Brain Barrier Disruption using FUS
Other Name: ExAblate
- Number of participants with treatment related Adverse Events as assessed by patient examination and MR imaging [ Time Frame: Treatment through Day 14 after Second Treatment ]Adverse events will be categorized according to severity, relationship to surgical procedure, and relationship to ExAblate device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608553
|Contact: Brian Ostranderfirstname.lastname@example.org|
|HM Hospitales Puerta del Sur - CINAC||Recruiting|
|Móstoles, Madrid, Spain, 28938|
|Contact: Carmen Gasca, MD|