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Effect of continuous 2 MHz transcranial ultrasound as an adjunct to tenecteplase thrombolysis in acute anterior circulation ischemic stroke patients: an open labeled non-randomized clinical trial

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Abstract

The treatment of acute ischemic stroke has improved in last few decades. While meta-analyses of several trials have established the safety and efficacy of Intravenous (IV) Tenecteplase thrombolysis, concomitant continuous transcranial doppler (TCD) ultrasound administration has not been assessed in any clinical trial. The aim of this study was to determine the effects of continuous 2 MHz TCD ultrasound during IV Tenecteplase thrombolysis for Middle cerebral artery (MCA) stroke. A total of 19 patients were included, 13 received TCD ultrasound and 6 sham TCD with IV Tenecteplase. TCD spectrum and difference in Pre and post TCD parameters were measured. Asymptomatic hemorrhagic transformation of infarct was seen in two patients. There was no mortality or clinical worsening in the sonothrombolysis group as against sham sonothrombolysis group. Median of peak systolic velocity was increased in both the sonothrombolysis (P = 0.0002) and sham sonothrombolysis group (P-value = 0.001). The difference in change in mean flow velocity between two groups, sonothrombolysis (11 cm/sec) and sham sonothrombolysis (3.5 cm/sec) were also significantly different (P = 0.014). This pilot work has established safety of continuous 30 min TCD application along with IV Tenecteplase thrombolysis and it concludes that concomitant 2 MHz TCD ultrasound administration significantly increased the MCA blood flow compared to chemothrombolysis alone.

CTRI Registered Number: CTRI/2021/02/031418.

Highlights

  • The study demonstrates that chemothrombolysis with Tenecteplase in anterior circulation ischemic strokes augments cerebral blood flow velocity evident from TCD spectral parameters of peak systolic velocity and mean flow velocity.

  • Further it showed when IV thrombolysis is combined with continuous 30 min transcranial ultrasound, the increase in cerebral blood flow is significantly augmented, suggesting an independent effect of simultaneous ultrasound exposure.

  • The combination of continuous TCD with IV Tenecteplase did not enhance the hemorrhagic complications or mortality confirming the safety of the procedure in acute ischemic stroke.

  • Whether the mechanism of augmentation of flow velocities is due to clot lysis or acceleration of fluid movement due to ultrasound energised fluid particles remains yet to be determined, but it has beneficial effects without compromising safety.

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Data availability

Raw data ia available with the Postgraduate thesis repository (MSc Neurotechnology; 2022) of the JIPMER Research Council and also with the authors on request.

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Acknowledgements

We Acknowledge JIPMER Research council for the administrative support for the M.Sc. Neurotechnology research work. We acknowledge Mr. Vadivelan.V, Senior Neurosonography Technician, JIPMER for technical guidance.

Funding

This work was funded by the Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry.

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Authors and Affiliations

  1. Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvanthari Nagar, Puducherry, 605006, India

    Semparuthi Arumugham, Sunil K. Narayan & Rajeswari Aghoram

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  1. Semparuthi Arumugham
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  3. Rajeswari Aghoram
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Correspondence to Sunil K. Narayan.

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We confirm that the experimental protocol was approved by JIPMER Institute Ethics Committee (JIEC) for Human Interventional studies and that informed consent for the study was obtained from all human subjects, in accordance with the World Medical Association Declaration of Helsinki (Ethical principles for medical research involving human subjects, 2013).

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Arumugham, S., Narayan, S.K. & Aghoram, R. Effect of continuous 2 MHz transcranial ultrasound as an adjunct to tenecteplase thrombolysis in acute anterior circulation ischemic stroke patients: an open labeled non-randomized clinical trial. J Thromb Thrombolysis (2024). https://doi.org/10.1007/s11239-023-02922-7

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