An injectable implant to stimulate the sphenopalatine ganglion for treatment of acute ischaemic stroke up to 24 h from onset (ImpACT-24B): an international, randomised, double-blind, sham-controlled, pivotal trial

Bornstein, Natan M.; Saver, Jeffrey L.; Diener, Hans Christoph; Gorelick, Philip B.; Shuaib, Ashfaq; Solberg, Yoram; Thackeray, Lisa; Savić, Milan; Janelidze, Tamar; Zarqua, Natia; Yarnitsky, David; Hill, Michael D.; Václavík, Daniel; Školoudík, David; Fiksa, Jan; Andersen, Grethe; Jäkälä, Pekka; Tatlısumak, Turgut; Kuzmanovski, Igor; Guillon, Benoı̂t; Chabriat, Hugues; Mahagne, Marie Hélène; Timsit, Serge; Ronzière, Thomas; Ingorokva, G.; Beridze, Maya; Beridze, M.; Kharaishvili, Nino; Kakabadze, Nodar; Griewing, B.; Hobohm, Carsten; Schneider, Dietmar; Weimar, Christian; Poppert, Holger; Kimmig, H.; Berrouschot, J.; Ringleb, Peter A.; Schwab, Stefan; Köhrmann, Martin; Kallmünzer, Bernd; Kollmar, Rainer; Endres, Matthias; Hausler, Karl-Georg; Cheung, Raymond; Leung, Thomas Wai Hong; Dorodnicov, E.; Halevi, Hen; Auriel, Eitan; Streifler, Jonathan Y.; Leker, Ronen R.; Schwammenthal, Yvonne; Toni, Danilo; Agnelli, Giancarlo; Caso, Valeria; Słowik, Agnieszka; Członkowska, Anna; Lubiński, I; Kochanowicz, Jan; Sobolewski, Piotr; Brola, Waldemar; Salgado, A; Correia, Carlos; Azevedo, Elsa; Roriz, José Mário; Žarkov, Marija; Petrovic, Zarko; Krastev, Georgi; Dvorak, Miloslav; Campello, Ana Rodríguez; Núñez, A. Gil; Molina, Carlos A.; Purroy, Francisco; Martí‐Fàbregas, Joan; Arenillas, Juan F.; Alonso, María Dolores; Cardona, Pedro; González, Miguel Blanco; Tur, Sílvia; Martín, Tomás Segura; Anzhelika, Payenok; Shownkeen, Harish; Concha, Mauricio; Sethi, Pramod; Sen, Souvik; Zaidi, Syed; Devlin, Thomas

doi:10.1016/s0140-6736(19)31192-4

Cited by 45 publications

(49 citation statements)

References 24 publications

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“…Implantation was a bedside, minimally invasive procedure in which the neurostimulator electrode (23 mm long, 2 mm in diameter) was injected into the pterygopalatine canal near the SPG. 11 , 12 The implant placement used an advanced software algorithm that automatically registered the patient’s preprocedure CT scan with the navigation system’s real-time optical tracking information (Figure I in the online-only Data Supplement ). A CT-opaque marker and an optical reference marker were attached to the patient at a fixed relative displacement using a dental impression of the upper palate and teeth (Figure II in the online-only Data Supplement ).…”

Section: Methodsmentioning

confidence: 99%

“… 7 – 10 Two large, randomized, sham-controlled clinical trials in AIS patients provided evidence that SPG stimulation improved final disability outcome in anterior circulation ischemic stroke patients with confirmed cortical involvement at entry—the ImpACT-24A (Implant for Augmentation of Cerebral Blood Flow Trial A) and ImpACT-24B. 11 , 12 In pooled analysis of the 2 trials, SPG stimulation in patients with confirmed cortical involvement increased 3-month favorable disability outcomes from 38.3% to 49.7% ( P =0.004). In addition, the benefit accrued in an inverted U-shaped dose-response pattern, with the greatest improvement in disability outcomes at low to medium stimulation intensities.…”

mentioning

confidence: 99%

“…In addition, the benefit accrued in an inverted U-shaped dose-response pattern, with the greatest improvement in disability outcomes at low to medium stimulation intensities. 12 …”

mentioning

confidence: 99%

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Refined Sphenopalatine Ganglion Stimulator Placement and Intensity Setting to Augment Blood Flow and Neurologic Function

Saver

Kharaishvili²,

Janelidze³

et al. 2019

Stroke

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Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

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Refined Sphenopalatine Ganglion Stimulator Placement and Intensity Setting to Augment Blood Flow and Neurologic Function

Saver

Kharaishvili²,

Janelidze³

et al. 2019

Stroke

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“…1,08-6,73); p = 0,03), was auf die höhere physiologische Bedeutung leptomeningealer Kollateralen zurückgeführt wurde. In der Folgestudie ImpACT-24B [80] wurden 1000 nicht thrombolysierte Patienten bis 24 Stunden nach Symptombeginn mit einem NIHSS von 7-18 eingeschlossen, in welcher sich insgesamt ebenfalls ein nicht signifikanter Trend für eine Chance auf ein besser als zu erwartendes Outcome nach SPG-Stimulation zeigte, wohingegen es in der CCI-Subgruppe (OR 1,48, 1,05-2,10; p = 0,026) signifikant häufiger zu einer Verbesserung über das erwartete Maß hinaus kam.…”

Section: Ganglion-sphenopalatinum-stimulation - Impact-24unclassified

Therapie des akuten ischämischen Schlaganfalls

Schlemm¹,

Kestner²,

Bohmann³

et al. 2020

Nervenheilkunde

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ZUSAMMENFASSUNGDie Behandlungsmöglichkeiten des akuten ischämischen Schlaganfalls haben sich durch Weiterentwicklung bewährter und Erprobung neuer Therapieansätze in den letzten Jahren verbessert. Durch den Einsatz der erweiterten Akutbildgebung mittels multimodaler Computer- oder Magnetresonanztomografie konnte der Zugang zu Thrombolyse und Thrombektomie auch für ausgewählte Patienten mit unbekanntem oder bis zu 9 bzw. 24 h zurückliegendem Beginn der akuten Schlaganfallsymptomatik ermöglicht werden. Ergänzend zu diesen rekanalisierenden Akuttherapien zeigen adjuvante neuroprotektive und immunmodulatorische Behandlungsansätze vielversprechende Ergebnisse. Schließlich gewinnen eine verbesserte Zusammenarbeit der an der Schlaganfallversorgung beteiligten Fachdisziplinen und die Optimierung logistischer Prozesse an Bedeutung, um den zeitabhängigen Nutzen der Akuttherapie individuell zu maximieren. Der vorliegende Artikel fasst wesentliche aktuelle Studienergebnisse zur Akuttherapie des ischämischen Schlaganfalls zusammen und gibt Empfehlungen für eine evidenzbasierte Bildgebung als Grundlage effektiver Reperfusionstherapien.

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“…As it was observed, it is safe therapy for patients with acute ischemic stroke, who were not classified to actual treatment, diagnosed between 8 and 24 hours after showing of outcomes and it can improve patients' activity. Now we have loads of hypothesis associated with beneficial effects of this therapy (increase in blood flow, neuronal recovery), but there is still a need of further studies, which may help with fitting the best doses, intensity and technical procedures to brighten effects of the method [45].…”

Section: Brain Stimulationmentioning

confidence: 99%

New directions in treatment of the ischemic stroke

Zaremba

Gorecka

Wysokińska

et al. 2020

J Educ Health Sport

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Stroke remains a leading cause of death and disability worldwide. The cause is decrease or total blocking of blood perfusion in brain and fast recognition is essential to conduct proper treatment. Currently commonly used methods are thrombolysis and mechanical thrombectomy, which high efficacy is observed only if they are performed within a few hours of the first symptoms. Hence loads of people, who are diagnosed later, become unable to undergo effective treatment. In the study are presented pathogenesis, epidemiology, classification, diagnosis and current treatment of the disease, but the main aim of the study is to present the results of the reports on new treatments for ischemic stroke. The research method is a review of the available literature published in PubMed, UpToDate and Google scholar databases. In the study were reviewed new methods, which can be alternative for currently used ones. They are small molecules including fluoxetine, aripiprazole, L-DOPA, cholinergic and 67 noradrenergic drugs, growth factors (HCG, EPO), monoclonal antibodies, allogenic stem cells, neurostimulators, robotic therapy and telerehabilitation. They give hope for curing a larger number of patients and improving effects of rehabilitation after ischemic stroke. However most of the methods, which are presented in this study require the use of tests that will allow checking their safety and application.

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An injectable implant to stimulate the sphenopalatine ganglion for treatment of acute ischaemic stroke up to 24 h from onset (ImpACT-24B): an international, randomised, double-blind, sham-controlled, pivotal trial

Cited by 45 publications

References 24 publications

Refined Sphenopalatine Ganglion Stimulator Placement and Intensity Setting to Augment Blood Flow and Neurologic Function

Refined Sphenopalatine Ganglion Stimulator Placement and Intensity Setting to Augment Blood Flow and Neurologic Function

Therapie des akuten ischämischen Schlaganfalls

New directions in treatment of the ischemic stroke

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