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NCT02540109 · ClinicalTrials.gov registry record · Phase 2

Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study

A Phase 2 study, sponsored by Soterix Medical.

Completed
Registry status
Phase 2
Development phase
58
Enrollment target

NCT02540109 is a Phase 2 study that has completed, run by Soterix Medical. The registered enrollment target is 58 participants.

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The verdict

NCT02540109, a Phase 2 study, has completed, sponsored by Soterix Medical.

COMPLETED
Registry status
Phase 2
Development phase
58 participants
Enrollment target

Study Summary

This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. These results will be compared to an existing trial using conventional non-targeted tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while performing computerized anomia treatment. The basis behind this method is that language therapy is mediated by cortical areas that are most effectively activated during the training tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To better understand the long term benefits of the adjunctive treatment, patients will be screened again four weeks and six months after study using the same anomia tests. If HD-tDCS shows promising results in increasing the learning outcomes of anomia treatment, a Phase III trial can be considered.

Interventions

  • DEVICE HD-tDCS (Soterix Medical, Active)
  • DEVICE HD-tDCS (Soterix Medical, Sham)

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2015-07
Est. Completion 2019-09
Phase Phase 2

Sponsor

Soterix Medical

8 total trials

What the Registry Record Tells You About NCT02540109

The ClinicalTrials.gov registry entry for NCT02540109 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Soterix Medical, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which HD-tDCS (Soterix Medical, Active) is the first listed.

NCT02540109 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02540109 about?

NCT02540109 is a clinical study titled "Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study". This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. These results w...

What is the current status of trial NCT02540109?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2015-07. Estimated completion is 2019-09.

What interventions are being tested in trial NCT02540109?

The interventions under investigation include: HD-tDCS (Soterix Medical, Active) (DEVICE), HD-tDCS (Soterix Medical, Sham) (DEVICE).

Who is sponsoring clinical trial NCT02540109?

This trial is sponsored by Soterix Medical, which has 8 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.