Parkinsons Disease With DementiaNCT03608553
A Study to Evaluate Temporary Blood Brain Barrier Disruption in Patients With Parkinson's Disease Dementia
A study testing MR Guided Focused Ultrasound in people with Parkinsons Disease With Dementia, run by InSightec at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Parkinsons Disease With Dementia
- What is being tested?
- MR Guided Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 26 Nov 2018to 9 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Primary Inclusion Criteria:
- 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).
Primary Exclusion Criteria:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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:
- Safety of BBB disruption
- Feasibility of disruption the BBB
- Reversibility of BBB disruption
- Reproducibility of BBB disruption
- Conditions
- Parkinsons Disease With Dementia
- Being tested
- MR Guided Focused Ultrasound
- Keywords
- MRgFUS, BBB, Blood Brain Barrier Disruption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR Guided Focused UltrasoundDevice
Also called ExAblate
Blood Brain Barrier Disruption using FUS
| Study group | Role | What they receive |
|---|---|---|
| ExAblate | Experimental | ExAblate MR Guided Focused Ultrasound Receives: Device: MR Guided Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Treatment through Day 14 after Second Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start26 Nov 2018
- Primary completion31 Oct 2021
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinsons Disease With DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Obeso, MD, PhD, Principal investigator, Director of CINAC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608553
- Sponsor's protocol ID
- PD008
- Status last verified
- Mar 2026
- First submitted
- 1 Mar 2018
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35765711Gasca-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.
PubMed 33536430
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03608553
- Acronym / sponsor ID
- PD008
- Conditions
- Parkinsons Disease With Dementia
- Keywords
- MRgFUS, BBB, Blood Brain Barrier Disruption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Safety of BBB disruption
- Feasibility of disruption the BBB
- Reversibility of BBB disruption
- Reproducibility of BBB disruption
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate | Experimental | Device: MR Guided Focused UltrasoundExAblate MR Guided Focused Ultrasound |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR Guided Focused UltrasoundAlso: ExAblateBlood Brain Barrier Disruption using FUS | Device | ExAblate |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Derived from this study: PubMed 35765711Pineda-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.
- Derived from this study: PubMed 33536430Gasca-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Obeso, MD, PhD principal investigator
Director of CINAC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Guided Focused Ultrasound in people with Parkinsons Disease With Dementia, run by InSightec at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608553, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.