NOn-invasive Repeated THerapeutic STimulation for Aphasia Recovery

Completed · Not applicable · Has a placebo group

Conditions studied: Aphasia

In brief

The current standard of care for rehabilitation of patients with aphasia after stroke is conventional speech and language therapy (SLT). Due to economic realities on most stroke units, SLT can often not be given with optimal intensity in the first weeks after the stroke. Developing new adjuvant therapies which may render SLT sessions more effective is thus one approach to improve rehabilitation outcome. Recent functional imaging studies in post-stroke aphasia have shown that the recruitment of brain regions in the unaffected hemisphere seems to be an inferior strategy for recovery of language function as compared to re-activation of brain regions in the vicinity of the infarct. Non-invasive brain stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) are new methods to modulate brain activity. Evidence from our own feasibility study in sub-acute stroke suggests that these new techniques, when applied in conjunction with conventional SLT, may help to normalize brain activation patterns and might yield better rehabilitation outcome than SLT alone. With NORTHSTAR, we propose a multicenter proof-of-concept study to investigate the safety, feasibility and efficacy of these new non-invasive brain stimulation methods as adjuvant therapies for subacute post-stroke aphasia. Our goal is to determine the most effective brain stimulation modality to decrease inhibition onto the left side of the brain. We will assess if a combination of brain stimulation and speech and language therapy will improve language recovery. We will quantify language recovery (expressive and comprehensive skills) using specific tests, commonly used by speech and language therapists. We will invite patients recently admitted to the stroke unit of the study centers to participate in our research project. Once patients consent to our study we will randomly assign them to one of three experimental groups. For 12 days, all groups of patients will be setup with brain stimulation during their usual rehabilitation sessions. Two of those groups (treatment groups) will each receive a different type of brain stimulation (rTMS and tDCS), in the third group, patients will not receive real stimulation (placebo group). By comparing the extent of aphasia recovery between groups, we will determine the benefits attributable to brain stimulation relative to SLT alone.

Key facts

Study ID: NCT02020421
Run by: Dr. Alexander Thiel
People needed: 63
Starts: 2013-12-01
Expected to finish: 2018-03-01
Last updated by the study team: 2021-10-26

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

ischemic stroke in the left MCA territory
between 5 and 30 days post stroke
right-handedness
English, French or German as language of daily use
score below the lower limit of the norm on at least one of the primary outcome measures

You may not qualify if…

prior symptomatic ischemic or hemorrhagic stroke
severe comprehension deficit that may compromise informed consent or understanding of instructions
contraindications to MRI and/or TMS/tDCS
neurodegenerative or psychiatric disease
epilepsy or EEG-documented epileptic discharges
chronic renal or liver failure
life-threatening diseases
auditory or visual deficits that cannot be corrected and might impair testing

Where it is running

Burke-Cornell Medical Research Institute — White Plains, New York, United States
Sunnybrook Research Institute — Toronto, Ontario, Canada
Toronto Rehabilitation Institute - UHN — Toronto, Ontario, Canada
CHUM Notre-Dame — Montreal, Quebec, Canada
Jewish General Hospital — Montreal, Quebec, Canada
Max-Planck-Institut für neurologische Forschung — Cologne, Germany

Full record on ClinicalTrials.gov

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