NCT03608553

A Study to Evaluate Temporary Blood Brain Barrier Disruption in Patients With Parkinson's Disease Dementia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

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: 1. Safety of BBB disruption 2. Feasibility of disruption the BBB 3. Reversibility of BBB disruption 4. Reproducibility of BBB disruption

Conditions

• Parkinsons Disease With Dementia

Interventions

Type	Name	Description
DEVICE	MR Guided Focused Ultrasound	Blood Brain Barrier Disruption using FUS

Timeline

• Start date: 2018-11-26
• Primary completion: 2021-10-31
• Completion: 2022-08-09
• First posted: 2018-08-01
• Last updated: 2026-03-20

Locations

1 site across 1 country: Spain