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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: Completed Phase 2 study, sponsored by Soterix Medical.
NCT02540109 is a Phase 2 study that has completed, run by Soterix Medical. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measures the ability of subjects to name objects in a standardized naming task. Prior to treatment MRI and fMRI are acquired to inform the individualized current flow models for optimal targeting.
Interventions
- DEVICE HD-tDCS (Soterix Medical, Active)
- DEVICE HD-tDCS (Soterix Medical, Sham)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2015-07 |
| Est. Completion | 2019-09 |
| Phase | Phase 2 |
What the finished NCT02540109 record still lists
NCT02540109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which HD-tDCS (Soterix Medical, Active) is the first listed.
NCT02540109 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02540109's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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