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Dextroamphetamine and tDCS to Improve the Fluency

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ClinicalTrials.gov Identifier: NCT02514044
Recruitment Status : Completed
First Posted : August 3, 2015
Results First Posted : August 3, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Gerard Francisco, The University of Texas Health Science Center, Houston

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Drug: Dexedrine Device: Active tDCS Behavioral: Speech Therapy Drug: Placebo Device: Sham tDCS Phase 2

Detailed Description:

Two phases were planned for this study, as described below. The safety phase of the study was completed; however, due to limited funding, the efficacy phase was never started (that is, the efficacy phase was terminated).

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation and Melodic Intonation Therapy Combined With Dextroamphetamine in Chronic Stroke Patients With Non-fluent Aphasia; Safety and Efficacy Phase
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: Dexedrine+sham tDCS+speech therapy
10 mg Dexedrine and speech therapy for 10 days
Drug: Dexedrine
10 mg immediate release of Dexedrine
Other Name: Adderall, Dexedrine

Behavioral: Speech Therapy
60 min of speech therapy
Other Name: Melodic Intonation Therapy

Device: Sham tDCS
Experimental: active tDCS+placebo+speech therapy
1.5 mA anodal tDCS and speech therapy for 10 days
Device: Active tDCS
1.5 mA tDCS anodal tDCS

Behavioral: Speech Therapy
60 min of speech therapy
Other Name: Melodic Intonation Therapy

Drug: Placebo
Experimental: Dexedrine+tDCS+speech therapy
10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 10 days
Drug: Dexedrine
10 mg immediate release of Dexedrine
Other Name: Adderall, Dexedrine

Device: Active tDCS
1.5 mA tDCS anodal tDCS

Behavioral: Speech Therapy
60 min of speech therapy
Other Name: Melodic Intonation Therapy

Experimental: sham stimulation+placebo+speech therapy
Sham stimulation, placebo and speech therapy for 10 days
Behavioral: Speech Therapy
60 min of speech therapy
Other Name: Melodic Intonation Therapy

Drug: Placebo
Device: Sham tDCS
Experimental: Dexedrine+tDCS+Speech Therapy
10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day
Drug: Dexedrine
10 mg immediate release of Dexedrine
Other Name: Adderall, Dexedrine

Device: Active tDCS
1.5 mA tDCS anodal tDCS

Behavioral: Speech Therapy
60 min of speech therapy
Other Name: Melodic Intonation Therapy

Experimental: placebo+tDCS+Speech Therapy
1.5 mA anodal tDCS, and speech therapy for 1 day
Device: Active tDCS
1.5 mA tDCS anodal tDCS

Behavioral: Speech Therapy
60 min of speech therapy
Other Name: Melodic Intonation Therapy

Drug: Placebo



Primary Outcome Measures :
  1. Percent Change in Language Quotient as Assessed by the Western Aphasia Battery [ Time Frame: immediately before the treatment, immediately after the treatment ]
    The score on the Language Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.

  2. Percent Change in Aphasia Quotient as Assessed by the Western Aphasia Battery [ Time Frame: immediately before the treatment, immediately after the treatment ]
    The score on the Aphasia Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.


Secondary Outcome Measures :
  1. Boston Diagnostic Aphasia Examination [ Time Frame: Baseline,2 weeks ]
  2. Boston Diagnostic Aphasia Examination [ Time Frame: Baseline,2 months ]
  3. Percent Change in Blood Pressure [ Time Frame: immediately before the treatment, after after the treatment ]
    Non-invasive BP measurements performed by a clinician before and after each experiment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514044


Locations
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United States, Texas
University of Texas Health Science Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Gerard E Francisco, MD University of Texas Health Science Center at Houston, Department of Physical Medicine and Rehabilitation

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Responsible Party: Gerard Francisco, Chairman and Clinical Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02514044     History of Changes
Other Study ID Numbers: HSC-MS-14-0354
First Posted: August 3, 2015    Key Record Dates
Results First Posted: August 3, 2018
Last Update Posted: August 3, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents