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NCT02020421 · ClinicalTrials.gov registry record · NA

NOn-invasive Repeated THerapeutic STimulation for Aphasia Recovery

A NA study of Aphasia, sponsored by Dr. Alexander Thiel.

Completed
Registry status
NA
Development phase
63
Enrollment target
6
Study locations

NCT02020421 is a NA study of Aphasia that has completed, run by Dr. Alexander Thiel. The registered enrollment target is 63 participants, below the 82-participant average among 42 other Aphasia trials with a reported enrollment target (23% lower). The trial reports 6 study locations across 4 states.

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The verdict

NCT02020421, a NA study of Aphasia, has completed, sponsored by Dr. Alexander Thiel.

COMPLETED
Registry status
NA
Development phase
63 participants
Enrollment target
6
Study locations

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

FieldValue
Enrollment Target 63 participants
Start Date 2013-12
Est. Completion 2018-03
Phase NA

Sponsor

Dr. Alexander Thiel

1 total trials

What the Registry Record Tells You About NCT02020421

The ClinicalTrials.gov registry entry for NCT02020421 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 82-participant average among 42 other Aphasia trials with a reported enrollment target (23% lower). The listed sponsor is Dr. Alexander Thiel, which has 1 total studies on file at ClinicalTrials.gov.

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.

NCT02020421 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Ontario, Quebec, New York.

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.

What interventions are being tested in trial NCT02020421?

The interventions under investigation include: Sham tDCS (DEVICE), Sham rTMS (DEVICE), tDCS (DEVICE), rTMS (DEVICE).

Who is sponsoring clinical trial NCT02020421?

This trial is sponsored by Dr. Alexander Thiel, which has 1 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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