NCT03608553

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2022

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

March 1, 2018

Last Update Submit

March 19, 2026

Conditions

Parkinsons Disease With Dementia

Keywords

MRgFUSBBBBlood Brain Barrier Disruption

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment related Adverse Events as assessed by patient examination and MR imaging

    Adverse events will be categorized according to severity, relationship to surgical procedure, and relationship to ExAblate device.

    Treatment through Day 14 after Second Treatment

Study Arms (1)

ExAblate

EXPERIMENTAL

ExAblate MR Guided Focused Ultrasound

Device: MR Guided Focused Ultrasound

Interventions

MR Guided Focused UltrasoundDEVICE

Blood Brain Barrier Disruption using FUS

Also known as: ExAblate
ExAblate

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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
  • Age: 60-80 years
  • Able to attend all study visits (i.e., life expectancy of 1 year).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HM Hospitales Puerta del Sur - CINAC

Móstoles, Madrid, 28938, Spain

Location

Related Publications (2)

  • Pineda-Pardo JA, Gasca-Salas C, Fernandez-Rodriguez B, Rodriguez-Rojas R, Del Alamo M, Obeso I, Hernandez-Fernandez F, Trompeta C, Martinez-Fernandez R, Matarazzo M, Mata-Marin D, Guida P, Duque A, Albillo D, Plaza de Las Heras I, Montero JI, Foffani G, Toltsis G, Rachmilevitch I, Blesa J, Obeso JA. Striatal Blood-Brain Barrier Opening in Parkinson's Disease Dementia: A Pilot Exploratory Study. Mov Disord. 2022 Oct;37(10):2057-2065. doi: 10.1002/mds.29134. Epub 2022 Jun 28.

    PMID: 35765711DERIVED

  • Gasca-Salas C, Fernandez-Rodriguez B, Pineda-Pardo JA, Rodriguez-Rojas R, Obeso I, Hernandez-Fernandez F, Del Alamo M, Mata D, Guida P, Ordas-Bandera C, Montero-Roblas JI, Martinez-Fernandez R, Foffani G, Rachmilevitch I, Obeso JA. Blood-brain barrier opening with focused ultrasound in Parkinson's disease dementia. Nat Commun. 2021 Feb 3;12(1):779. doi: 10.1038/s41467-021-21022-9.

    PMID: 33536430DERIVED

Study Officials

  • Jose Obeso, MD, PhD

    Director of CINAC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2018

First Posted

August 1, 2018

Study Start

November 26, 2018

Primary Completion

October 31, 2021

Study Completion

August 9, 2022

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

ES(1)