Phase 2
Completed N=10
Dextroamphetamine and tDCS to Improve the Fluency
Source: ClinicalTrials.gov NCT02514044 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Percent Change in Language Quotient as Assessed by the Western Aphasia Battery — 11.02; -4.2 percent change in language quotient — p=0.008
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Language Quotient as Assessed by the Western Aphasia Battery |
11.02; -4.2 | 0.008 sig |
| PRIMARY Percent Change in Aphasia Quotient as Assessed by the Western Aphasia Battery |
7.9; -.02 | 0.02 sig |
| SECONDARY Boston Diagnostic Aphasia Examination |
— | — |
| SECONDARY Percent Change in Blood Pressure |
10; 4; 11; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Age above 18
- Native English proficiency;
- Nonfluent speech;
- Premorbid right handedness;
- Non-hemorrhagic left hemispheric stroke at least 6 months prior to the investigation.
- No contraindications for MRI (only subjects who will undergo MRI scan).
Exclusion Criteria
- Hypersensitivity or idiosyncrasy to dextroamphetamine or to other sympathomimetic agents;
- Pregnant or trying to become pregnant;
- Active alcohol abuse, illicit drug use or drug abuse or significant mental illness;
- Subjects receiving alpha adrenergic antagonists or agonists;
- Any history of epilepsy;
- Any condition that would prevent the subject from giving voluntary informed consent;
- An implanted brain stimulator;
- Aneurysm clip or other metal in the brain;
- Enrolled or plans to enroll in an interventional trial during this study;
- Scalp wounds or infections;
- Previous stroke with residual deficits (TIAs not a reason for exclusion);
- A concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification > 3), or other major medical condition;
- Advanced atherosclerosis, Unstable cardiac dysrhythmia or uncontrolled hypertension (>160/100 mm Hg), or untreated hyperthyroidism;
- Diagnosis of glaucoma
- During or within 14 days following the administration of monoamine oxidase inhibitors;
- Subjects requiring palliative care;
- Terminal medical condition such as AIDS or cancer;
- Subjects unable to comprehend or follow verbal commands;
- Based on PI's or local physician's assessment patient unable to tolerate the trial procedure due to medical condition;
Data sourced from ClinicalTrials.gov (NCT02514044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.