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

March 17, 2021 updated by: InSightec

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Móstoles, Madrid, Spain, 28938
        • HM Hospitales Puerta del Sur - CINAC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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: 60-80 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ExAblate
ExAblate MR Guided Focused Ultrasound
Device: MR Guided Focused Ultrasound
Blood Brain Barrier Disruption using FUS
Other Names:
  • ExAblate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Treatment through Day 14 after Second Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSightec

Investigators

  • Principal Investigator: Jose Obeso, MD, PhD, Director of CINAC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 26, 2018

Primary Completion (ANTICIPATED)

October 31, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (ACTUAL)

August 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinsons Disease With Dementia

Clinical Trials on MR Guided Focused Ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe