Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2015-03-31
2015-12-31
Brief Summary
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Detailed Description
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SAFETY PHASE: 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. In the experiment 1, the subjects will receive 10 mg dextroamphetamine, 1.5 mA anodal tDCS to right inferior frontal gyrus (right Broca's area), and melodic intonation therapy. The two experiments of one time intervention will be separated by 1 week of washout and when the subjects come back for experiment 2, any later side effects will be evaluated. In the experiment 2, the subjects will receive placebo medication with anodal tDCS to right IFG (Broca's area) and melodic intonation therapy. During the experiments, thirty minutes before stimulation, participants in the active drug experiment (n=10) will take 10 mg dextroamphetamine per oral -experiment 1- and participants in the placebo drug experiment will take placebo pill per oral -experiment 2-. During the 20 minute stimulation phase, the participants (n=10) will receive anodal tDCS (1.5 mA) on ipsilesional right inferior frontal gyrus (Broca's area). All participants will simultaneously receive melodic intonation therapy for duration of an hour during and after 20 minutes of stimulation.
EFFICACY PHASE: 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. The subjects from the previous step of the study will be asked to participate to this step. Thirty minutes before stimulation participants in the active drug groups, group 1 (n=12) and group 3 (n=12) will take dextroamphetamine 10 mg per oral and participants in the placebo groups, group 2 (n=12) and group 4 (n=12) will take placebo pill per oral. During the 20 minute stimulation phase, the participants in the active stimulation groups, groups 1 (n=12) and 2 (n=12) will receive anodal tDCS (1.5 mA) on right inferior frontal gyrus (Broca's area), and participants in the sham control groups, group 3 (n=12) and group 4 (n=12) will receive sham stimulation. All participants will simultaneously receive melodic intonation therapy for duration of an hour during and after 20 minutes of stimulation. Treatment will be administered at an intensity of 5 sessions per week for 2 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Dexedrine+sham tDCS+speech therapy
10 mg Dexedrine and speech therapy for 10 days
Dexedrine
10 mg immediate release of Dexedrine
Speech Therapy
60 min of speech therapy
Sham tDCS
active tDCS+placebo+speech therapy
1.5 mA anodal tDCS and speech therapy for 10 days
Active tDCS
1.5 mA tDCS anodal tDCS
Speech Therapy
60 min of speech therapy
Placebo
Dexedrine+tDCS+speech therapy
10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 10 days
Dexedrine
10 mg immediate release of Dexedrine
Active tDCS
1.5 mA tDCS anodal tDCS
Speech Therapy
60 min of speech therapy
sham stimulation+placebo+speech therapy
Sham stimulation, placebo and speech therapy for 10 days
Speech Therapy
60 min of speech therapy
Placebo
Sham tDCS
Dexedrine+tDCS+Speech Therapy
10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day
Dexedrine
10 mg immediate release of Dexedrine
Active tDCS
1.5 mA tDCS anodal tDCS
Speech Therapy
60 min of speech therapy
placebo+tDCS+Speech Therapy
1.5 mA anodal tDCS, and speech therapy for 1 day
Active tDCS
1.5 mA tDCS anodal tDCS
Speech Therapy
60 min of speech therapy
Placebo
Interventions
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Dexedrine
10 mg immediate release of Dexedrine
Active tDCS
1.5 mA tDCS anodal tDCS
Speech Therapy
60 min of speech therapy
Placebo
Sham tDCS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Gerard Francisco
Chairman and Clinical Professor
Principal Investigators
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Gerard E Francisco, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center at Houston, Department of Physical Medicine and Rehabilitation
Locations
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University of Texas Health Science Center
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-MS-14-0354
Identifier Type: -
Identifier Source: org_study_id
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