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2. Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial

Author

Trøseid, Marius, Arribas, José R., Assoumou, Lambert, Holten, Aleksander Rygh, Poissy, Julien, Terzić, Vida, Mazzaferri, Fulvia, Baño, Jesús Rodríguez, Eustace, Joe, Hites, Maya, Joannidis, Michael, Paiva, José-Artur, Reuter, Jean, Püntmann, Isabel, Patrick-Brown, Thale D. J. H., Westerheim, Elin, Nezvalova-Henriksen, Katerina, Beniguel, Lydie, Dahl, Tuva Børresdatter, Bouscambert, Maude, Halanova, Monika, Péterfi, Zoltán, Tsiodras, Sotirios, Rezek, Michael, Briel, Matthias, Ünal, Serhat, Schlegel, Martin, Ader, Florence, Lacombe, Karine, Amdal, Cecilie Delphin, Rodrigues, Serge, Tonby, Kristian, Gaudet, Alexandre, Heggelund, Lars, Mootien, Joy, Johannessen, Asgeir, Møller, Jannicke Horjen, Pollan, Beatriz Diaz, Tveita, Anders Aune, Kildal, Anders Benjamin, Richard, Jean-Christophe, Dalgard, Olav, Simensen, Victoria Charlotte, Baldé, Aliou, de Gastines, Lucie, del Álamo, Marta, Aydin, Burç, Lund-Johansen, Fridtjof, Trabaud, Mary-Anne, Diallo, Alpha, Halvorsen, Bente, Røttingen, John-Arne, Tacconelli, Evelina, Yazdanpanah, Yazdan, Olsen, Inge C., and Costagliola, Dominique

Published
2023
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3. Staged Bilateral MRI-Guided Focused Ultrasound Subthalamotomy for Parkinson Disease

Author

Martínez-Fernández, Raúl, primary, Natera-Villalba, Elena, additional, Rodríguez-Rojas, Rafael, additional, del Álamo, Marta, additional, Pineda-Pardo, Jose A., additional, Obeso, Ignacio, additional, Guida, Pasqualina, additional, Jiménez-Castellanos, Tamara, additional, Pérez-Bueno, Diana, additional, Duque, Alicia, additional, Mañez-Miró, Jorge U., additional, Gasca-Salas, Carmen, additional, Matarazzo, Michele, additional, Alonso-Frech, Fernando, additional, and Obeso, Jose A., additional

Published
2024
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5. Social Cognition in Parkinson's Disease after Focused Ultrasound Subthalamotomy: A Controlled Study.

Author

Guida, Pasqualina, Martínez‐Fernández, Raúl, Máñez‐Miró, Jorge U., del Álamo, Marta, Foffani, Guglielmo, Fernández‐Rodríguez, Beatriz, Monje, Mariana H.G., Obeso, Ignacio, Obeso, José A., and Gasca‐Salas, Carmen

Abstract

Social cognition (SC) encompasses a set of cognitive functions that enable individuals to understand and respond appropriately to social interactions. Although focused ultrasound subthalamotomy (FUS‐STN) effectively treats Parkinson's disease (PD) clinical motor features, its impact and safety on cognitive‐behavioral interactions/interpersonal awareness are unknown. This study investigated the effects of unilateral FUS‐STN on facial emotion recognition (FER) and affective and cognitive theory of mind (ToM) in PD patients from a randomized sham‐controlled trial (NCT03454425). Subjects performed SC evaluation before and 4 months after the procedure while still under blind assessment conditions. The SC assessment included the Karolinska Directed Emotional Faces task for FER, the Reading the Mind in the Eyes (RME) test for affective ToM, and The Theory of Mind Picture Stories Task (ToM PST) (order, questions, and total score) for cognitive ToM. The active treatment group showed anecdotal‐to‐moderate evidence of no worsening in SC after FUS‐STN. Anecdotal evidence for an improvement was recognized in the SC score changes, from baseline to post‐treatment, for the active treatment group compared with sham for the RME, ToM PST order, ToM PST total, FER total, and recognition of fear, disgust, and anger. This study provides the first evidence that unilateral FUS‐STN does not impair social cognitive abilities, indicating that it can be considered a safe treatment approach for this domain in PD patients. Furthermore, the results suggest FUS‐STN may even lead to some improvement in social cognitive outcomes, which should be considered as a preliminary finding requiring further investigation with larger samples sizes. © 2024 International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]

Published
2024
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10. Unilateral focused ultrasound subthalamotomy in early Parkinson's disease: a pilot study.

Author

Martínez Fernández, Raúl, Natera Villalba, Elena, Rodriguez-Rojas, Rafael, del Álamo, Marta, Pineda-Pardo, Jose A., Obeso, Ignacio, Mata-Marín, David, Guida, Pasqualina, Jimenez Castellanos, Tamara, Pérez-Bueno, Diana, Duque, Alicia, Máñez Miró, Jorge U., Gasca-Salas, Carmen, Matarazzo, Michele, and Obeso, Jose A.

Subjects
DEEP brain stimulation, SUBTHALAMIC nucleus, PARKINSON'S disease, ULTRASONIC imaging, PILOT projects, MOTOR cortex
Published
2024
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11. Unilateral focused ultrasound subthalamotomy in early Parkinson’s disease: a pilot study

Author

Martínez Fernández, Raúl, primary, Natera Villalba, Elena, additional, Rodriguez-Rojas, Rafael, additional, del Álamo, Marta, additional, Pineda-Pardo, Jose A, additional, Obeso, Ignacio, additional, Mata-Marín, David, additional, Guida, Pasqualina, additional, Jimenez-Castellanos, Tamara, additional, Pérez-Bueno, Diana, additional, Duque, Alicia, additional, Máñez Miró, Jorge U, additional, Gasca-Salas, Carmen, additional, Matarazzo, Michele, additional, and Obeso, Jose A, additional

Published
2023
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13. BBB opening with focused ultrasound in nonhuman primates and Parkinson’s disease patients: Targeted AAV vector delivery and PET imaging

Author

Blesa, Javier, primary, Pineda-Pardo, José A., additional, Inoue, Ken-ichi, additional, Gasca-Salas, Carmen, additional, Balzano, Tiziano, additional, Del Rey, Natalia López-González, additional, Reinares-Sebastián, Alejandro, additional, Esteban-García, Noelia, additional, Rodríguez-Rojas, Rafael, additional, Márquez, Raquel, additional, Ciorraga, María, additional, del Álamo, Marta, additional, García-Cañamaque, Lina, additional, Ruiz de Aguiar, Santiago, additional, Rachmilevitch, Itay, additional, Trigo-Damas, Inés, additional, Takada, Masahiko, additional, and Obeso, José A., additional

Published
2023
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14. Prospective Long-term Follow-up of Focused Ultrasound Unilateral Subthalamotomy for Parkinson Disease

Author

Martínez-Fernández, Raúl, primary, Natera-Villalba, Elena, additional, Máñez Miró, Jorge U., additional, Rodriguez-Rojas, Rafael, additional, Marta del Álamo, Marta, additional, Pineda-Pardo, José Ángel, additional, Ammann, Claudia, additional, Obeso, Ignacio, additional, Mata-Marín, David, additional, Hernández-Fernández, Frida, additional, Gasca-Salas, Carmen, additional, Matarazzo, Michele, additional, Alonso-Frech, Fernando, additional, and Obeso, Jose A., additional

Published
2023
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15. Nigrostriatal blood-brain barrier opening in Parkinson’s disease

Author

Gasca-Salas, Carmen, Pineda-Pardo, José A, Del Álamo, Marta, Jiménez, Tamara, Trompeta, Clara, Toltsis, Gabriella, Garcia-Cañamaque, Lina, Fernández-Rodríguez, Beatriz, Matarazzo, Michele, Plaza de las Heras, Isabel, Natera-Villalba, Elena, Martínez-Fernández, Raúl, Duque, Alicia, Ruiz de Aguiar, Santiago, Blesa, Javier, Rachmilevich, Itay, and Obeso, José A

Abstract

BackgroundThe nigrostriatal system is especially vulnerable to neurodegeneration in Parkinson’s disease (PD) and the blood-brain barrier (BBB) is a limiting factor for delivery of therapeutic agents to the brain. This pilot study aimed to demonstrate safety, feasibility and tissue penetration (by 18F-Choline-positron emission tomography (PET)) of MR-guided focused ultrasound (MRgFUS) simultaneous BBB opening (BBB-O) in the substantia nigra (SN) and putamen in PD.MethodsThree patients underwent MRgFUS for midbrain and putamen BBB-O. Patients were evaluated clinically and underwent brain MRI with gadolinium (baseline, 24 hours, 14 days and 3 months postprocedure). In two patients, BBB-O was repeated after 2–3 weeks, and 18F-Choline-PET was performed immediately after.ResultsThe right SN and putamen were simultaneously opened unilaterally in 3 patients once and the left SN in 1 patient in a different session. No severe clinical or neuroimaging adverse events developed in any patient. 18F-Choline-PET uptake was enhanced in the targeted SN and putamen regions.ConclusionBBB-O of the nigrostriatal system is a feasible and well-tolerated approach in patients with PD. 18F-Choline-PET uptake indicates penetration into the parenchyma after BBB-O, which suggests that the opening is functionally effective. This minimally invasive technique could facilitate delivery of putative neurorestorative molecules to brain regions vulnerable to neurodegeneration.

Published
2024
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16. Additional file 1 of Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial

Author

Trøseid, Marius, Arribas, José R., Assoumou, Lambert, Holten, Aleksander Rygh, Poissy, Julien, Terzić, Vida, Mazzaferri, Fulvia, Baño, Jesús Rodríguez, Eustace, Joe, Hites, Maya, Joannidis, Michael, Paiva, José-Artur, Reuter, Jean, Püntmann, Isabel, Patrick-Brown, Thale D. J. H., Westerheim, Elin, Nezvalova-Henriksen, Katerina, Beniguel, Lydie, Dahl, Tuva Børresdatter, Bouscambert, Maude, Halanova, Monika, Péterfi, Zoltán, Tsiodras, Sotirios, Rezek, Michael, Briel, Matthias, Ünal, Serhat, Schlegel, Martin, Ader, Florence, Lacombe, Karine, Amdal, Cecilie Delphin, Rodrigues, Serge, Tonby, Kristian, Gaudet, Alexandre, Heggelund, Lars, Mootien, Joy, Johannessen, Asgeir, Møller, Jannicke Horjen, Pollan, Beatriz Diaz, Tveita, Anders Aune, Kildal, Anders Benjamin, Richard, Jean-Christophe, Dalgard, Olav, Simensen, Victoria Charlotte, Baldé, Aliou, de Gastines, Lucie, del Álamo, Marta, Aydin, Burç, Lund-Johansen, Fridtjof, Trabaud, Mary-Anne, Diallo, Alpha, Halvorsen, Bente, Røttingen, John-Arne, Tacconelli, Evelina, Yazdanpanah, Yazdan, Olsen, Inge C., and Costagliola, Dominique

Abstract

Additional file 1. Online Appendix.

Published
2023
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17. Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project

Author

Kjølbæk, Louise, primary, Manios, Yannis, additional, Blaak, Ellen E, additional, Martínez, J. Alfredo, additional, Feskens, Edith J M, additional, Finlayson, Graham, additional, Andersen, Sabina S H, additional, Reppas, Kyriakos, additional, Navas-Carretero, Santiago, additional, Adam, Tanja C, additional, Hodgkins, Charo E, additional, del Álamo, Marta, additional, Lam, Tony, additional, Moshoyiannis, Hariklia, additional, Halford, Jason C G, additional, Harrold, Joanne A, additional, and Raben, Anne, additional

Published
2022
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19. Striatal Blood–Brain Barrier Opening in Parkinson's Disease Dementia: A Pilot Exploratory Study

Author

Pineda‐Pardo, José A., primary, Gasca‐Salas, Carmen, additional, Fernández‐Rodríguez, Beatriz, additional, Rodríguez‐Rojas, Rafael, additional, del Álamo, Marta, additional, Obeso, Ignacio, additional, Hernández‐Fernández, Frida, additional, Trompeta, Clara, additional, Martínez‐Fernández, Raúl, additional, Matarazzo, Michele, additional, Mata‐Marín, David, additional, Guida, Pasqualina, additional, Duque, Alicia, additional, Albillo, David, additional, Plaza de las Heras, Isabel, additional, Montero, Juan I., additional, Foffani, Guglielmo, additional, Toltsis, Gabriella, additional, Rachmilevitch, Itay, additional, Blesa, Javier, additional, and Obeso, José A., additional

Published
2022
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20. Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children : the SWEET project

Author

Kjølbæk, Louise, Manios, Yannis, Blaak, Ellen E., Alfredo Martínez, J., Feskens, Edith J.M., Finlayson, Graham, Andersen, Sabina S.H., Reppas, Kyriakos, Navas-Carretero, Santiago, Adam, Tanja C., Hodgkins, Charo E., Del Álamo, Marta, Lam, Tony, Moshoyiannis, Hariklia, Halford, Jason C.G., Harrold, Joanne A., Raben, Anne, Kjølbæk, Louise, Manios, Yannis, Blaak, Ellen E., Alfredo Martínez, J., Feskens, Edith J.M., Finlayson, Graham, Andersen, Sabina S.H., Reppas, Kyriakos, Navas-Carretero, Santiago, Adam, Tanja C., Hodgkins, Charo E., Del Álamo, Marta, Lam, Tony, Moshoyiannis, Hariklia, Halford, Jason C.G., Harrold, Joanne A., and Raben, Anne

Abstract

INTRODUCTION: The aim of this randomised controlled trial (RCT) is to investigate whether prolonged consumption of sweeteners and sweetness enhancers (S&SEs) within a healthy diet will improve weight loss maintenance and obesity-related risk factors and affect safety markers compared with sugar. METHODS AND ANALYSIS: SWEET (S&SEs: prolonged effects on health, obesity and safety) is a 1-year multicentre RCT including at least 330 adults with overweight (18-65 years, body mass index (BMI) >25 kg/m2) and 40 children (6-12 years, BMI-for-age >85th percentile). In an initial 2-month period, adults will consume a low-energy diet with the aim to achieve ≥5% weight loss. Children are advised to consume a generally healthy diet to maintain body weight, thus reducing their BMI-for-age z-score. In the following 10 months, participants will be randomised to follow a healthy ad libitum diet with or without S&SE products. Clinical investigations are scheduled at baseline, after 2, 6 and 12 months. The primary outcomes are body weight for efficacy and gut microbiota composition (in relation to metabolic health) for safety, both in adults. Secondary outcomes include anthropometry, risk markers for type-2 diabetes and cardiovascular diseases, questionnaires including, for example, food preferences, craving and appetite and tests for allergenicity. ETHICS AND DISSEMINATION: The trial protocol has been approved by the following national ethical committees; The research ethics committees of the capital region (Denmark), approval code: H-19040679, The medical ethics committee of the University Hospital Maastricht and Maastricht University (the Netherlands), approval code: NL70977.068.19/METC19-056s, Research Ethics Committee of the University of Navarra (Spain), approval code: 2019.146 mod1, Research Ethics Committee of Harokopio University (Greece), approval code: 1810/18-06-2019. The trial will be conducted in accordance with the Declaration of Helsinki. Results will be published in i

Published
2022

24. Efficacy and Safety of Baricitinib for the Treatment of Hospitalized Adults with Severe or Critical COVID-19 (Bari-SolidAct): A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Trial

Author

Trøseid, Marius, primary, Arribas, JR, additional, Assoumou, Lambert, additional, Holten, Aleksander Rygh, additional, Poissy, Julien, additional, Terzić, Vida, additional, Mazzaferri, Fulvia, additional, Rodríguez-Baño, Jesús , additional, Eustace, Joe, additional, Hites, Maya, additional, Joannidis, Michael, additional, Paiva, Jose-Artur, additional, Reuter, Jean, additional, Püntmann, Isabel, additional, Patrick-Brown, Thale, additional, Westerheim, Elin, additional, Nezvalova-Henriksen, Katerina, additional, Beniguel, Lydie, additional, Dahl, Tuva Børresdatter, additional, Bouscambert-Duchamp, Maude, additional, Halanova, Monika, additional, Peterfi, Zoltan, additional, Tsiodras, Sotirios, additional, Rezek, Michael, additional, Briel, Matthias, additional, Unal, Serhat, additional, Schlegel, Martin, additional, Ader, Florence, additional, Lacombe, Karine, additional, Amdal, Cecilie Delphin, additional, Serge Rodrigues, Serge Rodrigues, additional, Tonby, Kristian, additional, Gaudet, Alexandre, additional, Heggelund, Lars, additional, Mootien, Joy, additional, Johannessen, Asgeir, additional, Møller, Jannicke Horjen, additional, Diaz Pollan, Beatriz, additional, Tveita, Anders, additional, Kildal, Anders Benjamin, additional, Richard, Jean-Christophe, additional, Dalgard, Olav, additional, Simensen, Victoria Charlotte, additional, Baldé, Aliou, additional, de Gastines, Lucie, additional, del Álamo, Marta, additional, Aydin, Burç, additional, Lund-Johansen, Fridtjof, additional, Trabaud, Mary-Anne, additional, Diallo, Alpha, additional, Halvorsen, Bente, additional, Røttingen, John-Arne, additional, Tacconelli, Evelina, additional, Yadanapanah, Yazdan, additional, Olsen, Inge Christoffer, additional, and Costagliola, Dominique, additional

Published
2022
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25. Bilateral staged magnetic resonance-guided focused ultrasound thalamotomy for the treatment of essential tremor: a case series study

Author

Martínez-Fernández, Raúl, Mahendran, Sujitha, Pineda-Pardo, Jose Angel, Imbach, Lukas L, Máñez-Miró, Jorge U, Büchele, Fabian, Del Álamo, Marta, Rodriguez-Rojas, Rafael, Hernández-Fernández, Frida, Werner, Beat, Matarazzo, Michele, Obeso, Ignacio, Gonzalez-Quarante, Lain H, Deuschl, Günther, Stieglitz, Lennart, Baumann, Christian R, Obeso, Jose A, and University of Zurich

Subjects
10180 Clinic for Neurosurgery, 10036 Medical Clinic, 610 Medicine & health, 10040 Clinic for Neurology
Published
2021

28. Bilateral staged magnetic resonance-guided focused ultrasound thalamotomy for the treatment of essential tremor: a case series study

Author

Martínez-Fernández, Raúl, primary, Mahendran, Sujitha, additional, Pineda-Pardo, Jose Angel, additional, Imbach, Lukas L, additional, Máñez-Miró, Jorge U, additional, Büchele, Fabian, additional, del Álamo, Marta, additional, Rodriguez-Rojas, Rafael, additional, Hernández-Fernández, Frida, additional, Werner, Beat, additional, Matarazzo, Michele, additional, Obeso, Ignacio, additional, Gonzalez-Quarante, Lain H, additional, Deuschl, Günther, additional, Stieglitz, Lennart, additional, Baumann, Christian R, additional, and Obeso, Jose A, additional

Published
2021
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29. Randomized Trial of Focused Ultrasound Subthalamotomy for Parkinson’s Disease

Author

Martínez-Fernández, Raúl, primary, Máñez-Miró, Jorge U., additional, Rodríguez-Rojas, Rafael, additional, del Álamo, Marta, additional, Shah, Binit B., additional, Hernández-Fernández, Frida, additional, Pineda-Pardo, José A., additional, Monje, Mariana H.G., additional, Fernández-Rodríguez, Beatriz, additional, Sperling, Scott A., additional, Mata-Marín, David, additional, Guida, Pasqualina, additional, Alonso-Frech, Fernando, additional, Obeso, Ignacio, additional, Gasca-Salas, Carmen, additional, Vela-Desojo, Lydia, additional, Elias, W. Jeffrey, additional, and Obeso, José A., additional

Published
2020
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30. Blood-Brain Barrier Opening with Focused Ultrasound in Parkinson’s Disease Dementia: A Safety and Feasibility Study (1131)

Author

Gasca-Salas, Carmen, primary, Fernández-Rodríguez, Beatriz, additional, Pineda-Pardo, José Ángel, additional, Rodríguez-Rojas, Rafael, additional, Hernández, Frida, additional, Obeso, Ignacio, additional, Marín, David Mata, additional, Guida, Pasqualina, additional, del Álamo, Marta, additional, Bandera, Carlos Ordás, additional, Rachmilevitch, Itay, additional, and Obeso, José A., additional

Published
2020
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31. Focused Ultrasound Subthalamotomy in Parkinson’s Disease: Lesion Topography and Motor Improvement. (1124)

Author

Máñez Miró, Jorge U., primary, Rodríguez-Rojas, Rafael, additional, Martínez-Fernández, Raúl, additional, Del Álamo, Marta, additional, Pineda-Pardo, José A., additional, Hernández-Fernández, Frida, additional, De Luis-Pastor, Esther, additional, Monje, MHG, additional, Fernández-Rodríguez, Beatriz, additional, Alonso-Frech, Fernando, additional, Vela, Lydia, additional, and Obeso, José A., additional

Published
2020
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34. Cognitive safety after unilateral magnetic resonance-guided focused ultrasound thalamotomy for essential tremor

Author

Gasca-Salas, Carmen, Guida, Pasqualina, Piredda, Rosanna, Obeso, Ignacio, Vela-Desojo, Lydia, Martínez-Fernández, Raúl, Hernández-Fernández, Frida, Máñez-Miró, Jorge, Pineda-Pardo, José A., Del Álamo, Marta, Rodriguez-Rojas, Rafael, Mata-Marín, David, Alonso-Frech, Fernando, Luis, Esther de, Obeso, Jose Angel, Gasca-Salas, Carmen, Guida, Pasqualina, Piredda, Rosanna, Obeso, Ignacio, Vela-Desojo, Lydia, Martínez-Fernández, Raúl, Hernández-Fernández, Frida, Máñez-Miró, Jorge, Pineda-Pardo, José A., Del Álamo, Marta, Rodriguez-Rojas, Rafael, Mata-Marín, David, Alonso-Frech, Fernando, Luis, Esther de, and Obeso, Jose Angel

Abstract

Essential tremor (ET) is the most common movement disorder, affecting 1% of the population worldwide. There is sound evidence that medically refractory tremor improves with thalamotomy and deep brain stimulation (DBS) targeting the thalamic ventralis intermedius nucleus (VIM). In the last few years, the incisionless technique of magnetic resonance- guided focused ultrasound (MRgFUS) has been demonstrated to be an effective procedure for unilateral thalamotomy,1 with a positive profile with regard to side effects. The thalamus is involved in cognitive functions such as attention/executive control, memory and language. Focal ablation of the thalamus, even when targeting a sensorimotor region as the VIM, raises question about potential cognitive side effects. After unilateral VIM-DBS in 40 patients with ET, Fields et al2 showed statistically significant improvements in visuoperceptual function and verbal memory. There was no significant decline in any measure, but four patients with preoperative low verbal fluency showed a further decline. Most studies have shown reduced verbal fluency under active VIM-DBS.2–4 Since focused ultrasound thalamotomy is a less invasive procedure, we hypothesised that the risk of procedure-related cognitive decline is further reduced.

Published
2019

35. Cognitive safety after unilateral magnetic resonance-guided focused ultrasound thalamotomy for essential tremor

Author

Gasca-Salas, Carmen, primary, Guida, Pasqualina, additional, Piredda, Rosanna, additional, Obeso, Ignacio, additional, Vela Desojo, Lydia, additional, Martínez-Fernández, Raúl, additional, Hernández-Fernández, Frida, additional, Máñez-Miró, Jorge, additional, Pineda-Pardo, José A, additional, del Álamo, Marta, additional, Rodriguez-Rojas, Rafael, additional, Mata-Marín, David, additional, Alonso-Frech, Fernando, additional, de Luis, Esther, additional, and Obeso, Jose Angel, additional

Published
2019
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39. Effect of macromolecular crowding agents on human immunodeficiency virus type 1 capsid protein assembly in vitro

Author

del Álamo, Marta, Rivas, Germán, Mateu, Mauricio G., del Álamo, Marta, Rivas, Germán, and Mateu, Mauricio G.

Abstract

Previous studies on the self-assembly of capsid protein CA of human immunodeficiency virus type 1 (HIV-1) in vitro have provided important insights on the structure and assembly of the mature HIV-1 capsid. However, CA polymerization in vitro was previously observed to occur only at very high ionic strength. Here, we have analyzed the elects on CA assembly in vitro of adding unrelated, inert macromolecules (crowding agents), aimed at mimicking the crowded (very high macromolecular effective concentration) environment within the HIV-1 virion. Crowding agents induced fast and efficient polymerization of CA even at low (close to physiological) ionic strength. The hollow cylinders thus assembled were indistinguishable in shape and dimensions from those formed in dilute protein solutions at high ionic strength. However, two important differences were noted: (i) disassembly by dilution of the capsid-like particles was undetectable at very high ionic strength, but occurred rapidly at low ionic strength in the presence of a crowding agent, and (ii) a variant CA from a presumed infectious HIV-1 with mutations at the CA dimerization interface was unable to assemble at any ionic strength in the absence of a crowding agent; in contrast, this mutation allowed efficient assembly, even at low ionic strength, when a crowding agent was used. The use of a low ionic strength and inert macromolecules to mimic the crowded environment inside the HIV-1 virion may lead to a better in vitro evaluation of the effects of conditions, mutations or/and other molecules, including potential antiviral compounds, on HIV-1 capsid assembly, stability and disassembly. Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Published
2005

47. Focused ultrasound subthalamotomy in patients with asymmetric Parkinson's disease: a pilot study.

Author

Martínez-Fernández, Raul, Rodríguez-Rojas, Rafael, Del Álamo, Marta, Hernández-Fernández, Frida, Pineda-Pardo, Jose A, Dileone, Michele, Alonso-Frech, Fernando, Foffani, Guglielmo, Obeso, Ignacio, Gasca-Salas, Carmen, de Luis-Pastor, Esther, Vela, Lydia, and Obeso, José A

Subjects
*PARKINSON'S disease diagnosis, *DIENCEPHALON, *DIAGNOSTIC imaging, *MAGNETIC resonance imaging, *COMPUTERS in medicine, *HEALTH outcome assessment, *PARKINSON'S disease, *OPERATIVE surgery, *SURGICAL complications, *PILOT projects, *SURGERY, *PSYCHOLOGY
Abstract

Background: Ablative neurosurgery has been used to treat Parkinson's disease for many decades. MRI-guided focused ultrasound allows focal lesions to be made in deep brain structures without skull incision. We investigated the safety and preliminary efficacy of unilateral subthalamotomy by focused ultrasound in Parkinson's disease.Methods: This prospective, open-label pilot study was done at CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur in Madrid, Spain. Eligible participants had Parkinson's disease with markedly asymmetric parkinsonism. Patients with severe dyskinesia, history of stereotactic surgery or brain haemorrhage, a diagnosis of an unstable cardiac or psychiatric disease, or a skull density ratio of 0·3 or less were excluded. Enrolled patients underwent focused ultrasound unilateral subthalamotomy. The subthalamic nucleus was targeted by means of brain images acquired with a 3-Tesla MRI apparatus. Several sonications above the definitive ablation temperature of 55°C were delivered and adjusted according to clinical response. The primary outcomes were safety and a change in the motor status of the treated hemibody as assessed with part III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) in both off-medication and on-medication states at 6 months. Adverse events were monitored up to 48 h after treatment and at scheduled clinic visits at 1, 3, and 6 months after treatment. The study is registered with ClinicalTrials.gov, number NCT02912871.Findings: Between April 26 and June 14, 2016, ten patients with markedly asymmetric parkinsonism that was poorly controlled pharmacologically were enrolled for focused ultrasound unilateral subthalamotomy. By 6 months follow-up, 38 incidents of adverse events had been recorded, none of which were serious or severe. Seven adverse events were present at 6 months. Three of these adverse events were directly related to subthalamotomy: off-medication dyskinesia in the treated arm (one patient, almost resolved by 6 months); on-medication dyskinesia in the treated arm (one patient, resolved after levodopa dose reduction); and subjective speech disturbance (one patient). Four of the adverse events present at 6 months were related to medical management (anxiety and fatigue [one patient each] and weight gain [two patients]). The most frequent adverse events were transient gait ataxia (related to subthalamotomy, six patients), transient pin-site head pain (related to the head frame, six patients), and transient high blood pressure (during the procedure, five patients). Transient facial asymmetry (one patient) and moderate impulsivity (two patients) were also recorded. The mean MDS-UPDRS III score in the treated hemibody improved by 53% from baseline to 6 months in the off-medication state (16·6 [SD 2·9] vs 7·5 [3·9]) and by 47% in the on-medication state (11·9 [3·1] vs 5·8 [3·5]).Interpretation: MRI-guided focused ultrasound unilateral subthalamotomy was well tolerated and seemed to improve motor features of Parkinson's disease in patients with noticeably asymmetric parkinsonism. Large randomised controlled trials are necessary to corroborate these preliminary findings and to assess the potential of such an approach to treat Parkinson's disease.Funding: Fundación de investigación HM Hospitales and Insightec. [ABSTRACT FROM AUTHOR]

Published
2017
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