Dextroamphetamine and tDCS to Improve the Fluency

Recruiting

Phase 2 Results N/A

Trial Description

The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine (Dexedrine) and transcranial direct current stimulation with melodic intonation therapy 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.

Detailed Description

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.
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

Interventions

  • Speech therapy Behavioral
    Other Names: Melodic Intonation Therapy
    Intervention Desc: 60 min of speech therapy
    ARM 1: Kind: Experimental
    Label: Dexedrine+sham tDCS+speech therapy
    Description: 10 mg Dexedrine and speech therapy for 10 days
    ARM 2: Kind: Experimental
    Label: active tDCS+placebo+speech therapy
    Description: 1.5 mA anodal tDCS and speech therapy for 10 days
    ARM 3: Kind: Experimental
    Label: Dexedrine+tDCS+speech therapy
    Description: 10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 10 days
    ARM 4: Kind: Experimental
    Label: sham stimulation+placebo+speech therapy
    Description: Sham stimulation, placebo and speech therapy for 10 days
    ARM 5: Kind: Experimental
    Label: Dexdrine+tDCS+Speech Therapy
    Description: 10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day
    ARM 6: Kind: Experimental
    Label: placebo+tDCS+Speech Therapy
    Description: 1.5 mA anodal tDCS, and speech therapy for 1 day
  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: active tDCS+placebo+speech therapy
    Description: 1.5 mA anodal tDCS and speech therapy for 10 days
    ARM 2: Kind: Experimental
    Label: sham stimulation+placebo+speech therapy
    Description: Sham stimulation, placebo and speech therapy for 10 days
    ARM 3: Kind: Experimental
    Label: placebo+tDCS+Speech Therapy
    Description: 1.5 mA anodal tDCS, and speech therapy for 1 day
  • Sham tDCS Device
    ARM 1: Kind: Experimental
    Label: Dexedrine+sham tDCS+speech therapy
    Description: 10 mg Dexedrine and speech therapy for 10 days
    ARM 2: Kind: Experimental
    Label: sham stimulation+placebo+speech therapy
    Description: Sham stimulation, placebo and speech therapy for 10 days
  • Active tDCS Device
    Intervention Desc: 1.5 mA tDCS anodal tDCS
    ARM 1: Kind: Experimental
    Label: active tDCS+placebo+speech therapy
    Description: 1.5 mA anodal tDCS and speech therapy for 10 days
    ARM 2: Kind: Experimental
    Label: Dexedrine+tDCS+speech therapy
    Description: 10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 10 days
    ARM 3: Kind: Experimental
    Label: Dexdrine+tDCS+Speech Therapy
    Description: 10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day
    ARM 4: Kind: Experimental
    Label: placebo+tDCS+Speech Therapy
    Description: 1.5 mA anodal tDCS, and speech therapy for 1 day
  • Dexedrine Drug
    Other Names: Adderall, Dexedrine
    Intervention Desc: 10 mg immediate release of Dexedrine
    ARM 1: Kind: Experimental
    Label: Dexedrine+sham tDCS+speech therapy
    Description: 10 mg Dexedrine and speech therapy for 10 days
    ARM 2: Kind: Experimental
    Label: Dexedrine+tDCS+speech therapy
    Description: 10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 10 days
    ARM 3: Kind: Experimental
    Label: Dexdrine+tDCS+Speech Therapy
    Description: 10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Western Aphasia Battery Baseline,2 weeks No
Secondary Boston Diagnostic Aphasia Examination Baseline,2 weeks No

Sponsors