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NCT02514044 · ClinicalTrials.gov registry record · Phase 2

Dextroamphetamine and tDCS to Improve the Fluency

A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.

Completed
Registry status
Phase 2
Development phase
10
Enrollment target

NCT02514044 is a Phase 2 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 10 participants.

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The verdict

NCT02514044, a Phase 2 study, has completed, sponsored by The University of Texas Health Science Center, Houston.

COMPLETED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine (Dexedrine) and transcranial direct current stimulation (tDCS) with melodic intonation therapy (MIT) for treatment of aphasia after stroke. The target population is patients with chronic speech deficits due to a left hemisphere non-hemorrhagic stroke. Findings from this proposed project will help in the design of future larger studies.The safety phase will use cross-over, placebo controlled and single-blinded design. 10 participants with post stroke chronic non-fluent aphasia will undergo two experiments. To study the safety and effect of combined dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups, randomized, sham and placebo controlled, and double-blinded design in which 48 participants with post stroke chronic non-fluent aphasia will be randomly assigned to receive either 1) dextroamphetamine therapy with active stimulation, 2) placebo medication with active stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication with sham stimulation for the same duration.

Interventions

  • DRUG Placebo
  • DEVICE Sham tDCS
  • DEVICE Active tDCS
  • BEHAVIORAL Speech Therapy
  • DRUG Dexedrine

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2015-03
Est. Completion 2015-12
Phase Phase 2

What the Registry Record Tells You About NCT02514044

The ClinicalTrials.gov registry entry for NCT02514044 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT02514044 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02514044 about?

NCT02514044 is a clinical study titled "Dextroamphetamine and tDCS to Improve the Fluency". The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine (Dexedrine) and transcranial direct current stimulation (tDCS) with melodic intonation therapy (MIT) for treatment of aphasia after stroke. The target population is patients with chronic speech deficits due to a le...

What is the current status of trial NCT02514044?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2015-03. Estimated completion is 2015-12.

What interventions are being tested in trial NCT02514044?

The interventions under investigation include: Placebo (DRUG), Sham tDCS (DEVICE), Active tDCS (DEVICE), Speech Therapy (BEHAVIORAL), Dexedrine (DRUG).

Who is sponsoring clinical trial NCT02514044?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

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

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