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NOn-invasive Repeated THerapeutic STimulation for Aphasia Recovery
NCT02020421 · View on ClinicalTrials.gov ↗
Study Summary
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 group
Conditions Studied
Interventions
- DEVICE Sham tDCS
- DEVICE Sham rTMS
- DEVICE tDCS
- DEVICE rTMS
Study Locations (6)
Ontario
- Sunnybrook Research Institute — Toronto
- Toronto Rehabilitation Institute - UHN — Toronto
Quebec
- CHUM Notre-Dame — Montreal
- Jewish General Hospital — Montreal
New York
- Burke-Cornell Medical Research Institute — White Plains
Other
- Max-Planck-Institut für neurologische Forschung — Cologne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-12 |
| Est. Completion | 2018-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02020421
The ClinicalTrials.gov registry entry for NCT02020421 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dr. Alexander Thiel, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Aphasia appearing as the primary indexed condition, and to 4 interventions — of which Sham tDCS is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02020421 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Ontario, Quebec, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02020421 about?
NCT02020421 is a clinical study titled "NOn-invasive Repeated THerapeutic STimulation for Aphasia Recovery". 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 ther...
What is the current status of trial NCT02020421?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2013-12. Estimated completion is 2018-03.
What conditions does trial NCT02020421 study?
This clinical trial studies the following conditions: Aphasia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02020421?
The interventions under investigation include: Sham tDCS (DEVICE), Sham rTMS (DEVICE), tDCS (DEVICE), rTMS (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02020421?
This trial is sponsored by Dr. Alexander Thiel, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02020421 being conducted?
This trial has 6 study locations across New York, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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