NCT03608553

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

Completed NA Last updated 20 March 2026

What this trial tests

NA trial testing MR Guided Focused Ultrasound in Parkinsons Disease With Dementia in 20 participants. Completed in 9 August 2022.

Timeline

26 November 2018

Primary endpoint
31 October 2021

9 August 2022

Quick facts

Lead sponsor	InSightec
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	26 November 2018
Primary completion	31 October 2021
Estimated completion	9 August 2022
Sites	1 location across Spain

Drugs / interventions tested

• MR Guided Focused Ultrasound

Conditions studied

• Parkinsons Disease With Dementia — all drugs for Parkinsons Disease With Dementia →

Sponsor

InSightec — full company profile →

Who can join

Adults 60 to 80, any sex, with Parkinsons Disease With Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Blood-brain barrier opening with focused ultrasound in Parkinson's disease dementia.
   Gasca-Salas C, Fernández-Rodríguez B, Pineda-Pardo JA, Rodríguez-Rojas R, et al · · 2021 · cited 230× · PMID 33536430 · DOI 10.1038/s41467-021-21022-9
2. Functionalized Nanomaterials Capable of Crossing the Blood-Brain Barrier.
   Zha S, Liu H, Li H, Li H, et al · · 2024 · cited 168× · PMID 38193927 · DOI 10.1021/acsnano.3c10674
3. Current Strategies to Enhance Delivery of Drugs across the Blood-Brain Barrier.
   Teleanu RI, Preda MD, Niculescu AG, Vladâcenco O, et al · · 2022 · cited 122× · PMID 35631573 · DOI 10.3390/pharmaceutics14050987
4. Development of Novel Therapeutics Targeting the Blood-Brain Barrier: From Barrier to Carrier.
   Li J, Zheng M, Shimoni O, Banks WA, et al · · 2021 · cited 121× · PMID 34085418 · DOI 10.1002/advs.202101090
5. Theranostic Strategy of Focused Ultrasound Induced Blood-Brain Barrier Opening for CNS Disease Treatment.
   Chen KT, Wei KC, Liu HL. · · 2019 · cited 108× · PMID 30792657 · DOI 10.3389/fphar.2019.00086
6. Applications of focused ultrasound-mediated blood-brain barrier opening.
   Gorick CM, Breza VR, Nowak KM, Cheng VWT, et al · · 2022 · cited 95× · PMID 36272635 · DOI 10.1016/j.addr.2022.114583
7. Blood-Brain Barrier: More Contributor to Disruption of Central Nervous System Homeostasis Than Victim in Neurological Disorders.
   Xiao M, Xiao ZJ, Yang B, Lan Z, et al · · 2020 · cited 87× · PMID 32903669 · DOI 10.3389/fnins.2020.00764
8. Improving CNS Delivery to Brain Metastases by Blood-Tumor Barrier Disruption.
   Sprowls SA, Arsiwala TA, Bumgarner JR, Shah N, et al · · 2019 · cited 79× · PMID 31421906 · DOI 10.1016/j.trecan.2019.06.003