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A Study to Evaluate Temporary Blood Brain Barrier Disruption 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 : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
InSightec

Brief 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

Condition or disease Intervention/treatment Phase
Parkinsons Disease With Dementia Device: MR Guided Focused Ultrasound Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : December 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ExAblate
ExAblate MR Guided Focused Ultrasound
Device: MR Guided Focused Ultrasound
Blood Brain Barrier Disruption using FUS
Other Name: ExAblate




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Primary Inclusion Criteria:

  1. Parkinson´s Disease, according to the UK Parkinson´s Disease Society Brain Bank (Gelb et al. 1999)
  2. Parkinson´s Disease patients diagnosed with mild-moderate dementia according to the Movement Disorders Criteria (Emre et al. 2007)
  3. Able and willing to give informed consent, or has delegated this to a substitute decision maker.
  4. Mini Mental State Exam (MMSE) scores ≥16 (able to complete a Neuropsychological evaluation)
  5. Geriatric Depression Scale (GDS) score of ≤ 20
  6. Age: 60-75 years
  7. Able to attend all study visits (i.e., life expectancy of 1 year).

Primary Exclusion Criteria:

  1. Clips or other metallic implanted objects in the skull or the brain, except shunts
  2. Significant cardiac disease or unstable hemodynamic status
  3. Uncontrolled hypertension (systolic > 150 and diastolic BP > 100 on medication)
  4. 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
  5. History of a bleeding disorder
  6. Significant depression and at potential risk of suicide
  7. Known sensitivity/allergy to gadolinium
  8. Any contraindications to MRI scanning
  9. History of seizure disorder or epilepsy
  10. History of drug or alcohol use disorder who may be at higher risk for seizure, infection, or poor executive functioning
  11. Chronic breathing disorders

Information from the National Library of Medicine

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


Contacts
Contact: Carmen Gasca, MD, PhD +34 91 267 32 10 consulta.hmcinac@hmhospitales.com

Locations
Spain
HM Hospitales Puerta del Sur - CINAC Recruiting
Móstoles, Madrid, Spain, 28938
Contact: Carmen Gasca, MD         
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: Jose Obeso, MD, PhD Director of CINAC

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03608553     History of Changes
Other Study ID Numbers: PD008
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by InSightec:
MRgFUS
BBB
Blood Brain Barrier Disruption

Additional relevant MeSH terms:
Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders