Blood-brain barrier opening with focused ultrasound in Parkinson’s disease dementia

Carmen Gasca-Salas, Beatriz Fernández-Rodríguez, José A. Pineda-Pardo, Rafael Rodríguez-Rojas, Ignacio Obeso, Frida Hernández-Fernández, Marta Álamo, David Mata, Pasqualina Guida, Carlos Ordás-Bandera, J. Ignacio Montero-Roblas, Raúl Martínez-Fernández, Guglielmo Foffani, Itay Rachmilevitch and José A. Obeso ()
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Carmen Gasca-Salas: University Hospital HM Puerta del Sur. CEU-San Pablo University
Beatriz Fernández-Rodríguez: University Hospital HM Puerta del Sur. CEU-San Pablo University
José A. Pineda-Pardo: University Hospital HM Puerta del Sur. CEU-San Pablo University
Rafael Rodríguez-Rojas: University Hospital HM Puerta del Sur. CEU-San Pablo University
Ignacio Obeso: University Hospital HM Puerta del Sur. CEU-San Pablo University
Frida Hernández-Fernández: University Hospital HM Puerta del Sur. CEU-San Pablo University
Marta Álamo: University Hospital HM Puerta del Sur. CEU-San Pablo University
David Mata: University Hospital HM Puerta del Sur. CEU-San Pablo University
Pasqualina Guida: University Hospital HM Puerta del Sur. CEU-San Pablo University
Carlos Ordás-Bandera: Hospital Universitario Rey Juan Carlos
J. Ignacio Montero-Roblas: University Hospital HM Puerta del Sur
Raúl Martínez-Fernández: University Hospital HM Puerta del Sur. CEU-San Pablo University
Guglielmo Foffani: University Hospital HM Puerta del Sur. CEU-San Pablo University
Itay Rachmilevitch: Insightec LTD
José A. Obeso: University Hospital HM Puerta del Sur. CEU-San Pablo University

Nature Communications, 2021, vol. 12, issue 1, 1-7

Abstract: Abstract MR-guided focused ultrasound (MRgFUS), in combination with intravenous microbubble administration, has been applied for focal temporary BBB opening in patients with neurodegenerative disorders and brain tumors. MRgFUS could become a therapeutic tool for drug delivery of putative neurorestorative therapies. Treatment for Parkinson’s disease with dementia (PDD) is an important unmet need. We initiated a prospective, single-arm, non-randomized, proof-of-concept, safety and feasibility phase I clinical trial (NCT03608553), which is still in progress. The primary outcomes of the study were to demonstrate the safety, feasibility and reversibility of BBB disruption in PDD, targeting the right parieto-occipito-temporal cortex where cortical pathology is foremost in this clinical state. Changes in β-amyloid burden, brain metabolism after treatments and neuropsychological assessments, were analyzed as exploratory measurements. Five patients were recruited from October 2018 until May 2019, and received two treatment sessions separated by 2–3 weeks. The results are set out in a descriptive manner. Overall, this procedure was feasible and reversible with no serious clinical or radiological side effects. We report BBB opening in the parieto-occipito-temporal junction in 8/10 treatments in 5 patients as demonstrated by gadolinium enhancement. In all cases the procedures were uneventful and no side effects were encountered associated with BBB opening. From pre- to post-treatment, mild cognitive improvement was observed, and no major changes were detected in amyloid or fluorodeoxyglucose PET. MRgFUS-BBB opening in PDD is thus safe, reversible, and can be performed repeatedly. This study provides encouragement for the concept of BBB opening for drug delivery to treat dementia in PD and other neurodegenerative disorders.

Date: 2021
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DOI: 10.1038/s41467-021-21022-9

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