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Priming constraint-induced movement therapy with intermittent theta burst stimulation to enhance upper extremity recovery in patients with stroke: protocol for a randomized controlled study

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Abstract

Background

The treatments based on motor control and motor learning principles have gained popularity in the last 20 years, as well as non-invasive brain stimulations that enhance neuroplastic changes after stroke. However, the effect of intermittent theta burst stimulation (iTBS) in addition to evidence-based, intensive neurorehabilitation approaches such as modified constraint-induced movement therapy (mCIMT) is yet to be investigated.

Aim

We aim to establish a protocol for a randomized controlled study investigating the efficiency of mCIMT primed with iTBS after stroke.

Methods

In this randomized controlled, single-blind study, patients with stroke (N = 17) will be divided into 3 groups: (a) mCIMT + real iTBS, (b) mCIMT + sham iTBS, and (c) mCIMT alone. 600-pulse iTBS will be delivered to the primary motor cortex on the ipsilesional hemisphere, and then, patients will receive mCIMT for 1 h/session, 3 sessions/week for 5 weeks. Upper extremity recovery will be assessed with Fugl-Meyer Test-Upper Extremity and Wolf Motor Function Test. Electrophysiological assessments, such as Motor-Evoked Potentials, Resting Motor Threshold, Short-Intracortical Inhibition, and Intracortical Facilitation, will also be included.

Conclusions

In this study, a protocol of an ongoing intervention study investigating the effectiveness of iTBS on ipsilesional M1 prior to the mCIMT in patients with stroke is proposed. This will be the first study to research priming mCIMT with iTBS and it may have the potential to reveal the true effect of the iTBS when it is added to the high-quality neurorehabilitation approaches.

Trial registration

Trial registration number: NCT05308667

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Data availability

There are no linked data sets for this paper. The data are confidential, since the participant of this study were informed upon admission to the hospital that the data would remain confidential and would not be shared with third parties.

Code availability

Not applicable.

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Funding

This research did not receive any funding from agencies in the public, commercial, or not-for-profit sectors.

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Authors and Affiliations

  1. Department of Physiotherapy and Rehabilitation, Istanbul Medeniyet University, Istanbul, Turkey

    Esma Nur Kolbaşı

  2. Institute of Graduate Studies, Physiotherapy and Rehabilitation Department, Istanbul University-Cerrahpaşa, Istanbul, Turkey

    Esma Nur Kolbaşı

  3. Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Marmara University, Istanbul, Turkey

    Burcu Ersoz Huseyinsinoglu

  4. Department of Neurology, Bakırkoy Prof. Dr. Mazhar Osman Training and Research Hospital for Psychiatric, Neurologic and Neurosurgical Diseases, University of Health Sciences, Istanbul, Turkey

    Zeynep Ozdemir & Aysun Soysal

  5. Department of Physiology, International School of Medicine, Istanbul Medipol University, Istanbul, Turkey

    Zubeyir Bayraktaroglu

Authors
  1. Esma Nur Kolbaşı
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  3. Zeynep Ozdemir
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Contributions

Conceptualization: ENK, BEH, ZÖ, ZB, and AS; methodology: ENK, BEH, ZÖ, ZB, and AS; writing—original draft preparation: ENK, BEH, ZÖ, and ZB; writing—review and editing: BH, ZB, ZÖ, and AS; supervision: BEH, ZB, and AS.

Corresponding author

Correspondence to Burcu Ersoz Huseyinsinoglu.

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Ethical approval

The study was approved by Marmara University Faculty of Medicine Clinical Trials Ethics Committee (date 01.06.2022—no.09.2022.614) and administered according to the Ethical Principles for Medical Research Involving Human Subjects by the Helsinki Declaration.

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Kolbaşı, E.N., Huseyinsinoglu, B.E., Ozdemir, Z. et al. Priming constraint-induced movement therapy with intermittent theta burst stimulation to enhance upper extremity recovery in patients with stroke: protocol for a randomized controlled study. Acta Neurol Belg (2024). https://doi.org/10.1007/s13760-024-02472-6

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