Original Article
Non-invasive Repeated Therapeutic Stimulation for Aphasia Recovery: A Multilingual, Multicenter Aphasia Trial

https://doi.org/10.1016/j.jstrokecerebrovasdis.2014.10.021Get rights and content

Noninvasive brain stimulation such as repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used in case series and small randomized controlled trials to improve recovery from poststroke aphasia in combination with speech and language therapy. Results of these studies suggest possible clinical efficacy and an excellent safety profile. Therefore, a larger international multicenter proof-of-concept trial was launched, to directly compare the safety and efficacy of rTMS, tDCS, and sham stimulation as adjuvant therapy to speech and language therapy in subacute poststroke aphasia. In the 4 participating centers, subacute stroke patients with aphasia are randomized between 5 and 30 days after ischemic stroke to either receive rTMS, tDCS, or sham stimulation in combination with a daily 45 minutes speech and language therapy session for 10 days. Efficacy is evaluated at 1 and 30 days after the last of the 10 treatment sessions using 3 outcome measures, validated in all participating languages: Boston naming test, Token test, and verbal fluency test. Additionally, adverse events are recorded to prove safety. In this study, a total of 90 patients will be recruited, and data analysis will be completed in 2016. This is the first multilingual and multinational randomized and controlled trial in poststroke aphasia and if positive, will add an effective new strategy for early stage poststroke aphasia rehabilitation.

Section snippets

Design

NORTHSTAR is a 3-armed sham-controlled blinded prospective proof-of-concept study. Patients will be randomized to either sham or rTMS or tDCS treatment. Patients randomized to rTMS treatment will in addition receive sham tDCS, and patients with tDCS treatment will be receiving sham rTMS. Patients randomized to the sham group will receive both sham conditions. All patients will receive 45 minutes of model-oriented individualized aphasia therapy administered by a certified therapist and according

Rationale for Patient Selection and Stimulation Site

If noninvasive brain stimulation has the potential to become a clinically relevant adjunctive therapy for aphasia it has to have a broad applicability and needs to be cost effective. The eligibility criteria have thus been selected such that the resulting study population will reflect a typical clinical population of aphasic stroke patients. Stroke location and aphasia type are not inclusion or exclusion criteria but will be tracked with MRI to ensure a similar distribution between treatment

Conclusion

NORTHSTAR is the first multicenter proof-of-concept study, which seeks to directly compare 2 novel and experimental noninvasive brain stimulation methods as adjuvant therapy for rehabilitation of poststroke aphasia, based on the pathophysiologic concept of transcallosal inhibition, thus, potentially translating a novel, nonpharmacologic, model-driven approach to neurorehabilitation into clinical practice. In addition, this trial will address the more fundamental question of the equivalence of 2

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    The authors declare no conflicts of interest.

    The study was funded by Canadian Institutes for Health Research (MOP125954).

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