Post-stroke Neural Plasticity With Atomoxetine

Completed

Phase 2 Results N/A

Trial Description

This proposal evaluates the safety and effectiveness of a noradrenergic drug named atomoxetine combined with motor training to enhance cortical plasticity and improve hand function after stroke.

Detailed Description

Extensive studies in laboratory animals and humans over the last ten years indicate that some medications, especially amphetamine, given with specific physical therapy may improve motor learning (and therefore recovery from stroke) more than physical therapy alone. However, the number of patients in clinical trials who have received physical therapy and amphetamine is very small, for two reasons: because amphetamine may interact with many other medications that stroke patients are already taking, and because its potential for addiction precludes its use on a daily basis. The investigators now wish to evaluate the effectiveness of a more selective medication, atomoxetine, known to have many fewer side effects and no potential for drug addiction. The proposed mechanism by which amphetamine enhances recovery is by increasing central levels of norepinephrine. While the investigators already know that this drug is more selective than amphetamine, the investigators would like to evaluate its effects on hand motor learning and motor recovery in chronic stroke patients in a clinical setting.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
    ARM 1: Kind: Experimental
    Label: Placebo with motor training
    Description: Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
  • Atomoxetine Drug
    Other Names: Strattera
    Intervention Desc: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
    ARM 1: Kind: Experimental
    Label: Atomoxetine with motor training
    Description: 40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
    ARM 2: Kind: Experimental
    Label: Placebo with motor training
    Description: Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Fugl Meyer Assessment Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline No
Secondary Change in Action Arm Research Test (ARAT) Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline No
Secondary Change in Wolf Motor Function Test (WMFT) Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline No
Secondary Transcranial Magnetic Stimulation Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline No

Sponsors