RCT of a Neuroplasticity Agent and CI Therapy for Severe Arm Paresis After Stroke

Withdrawn

Phase 2 Results N/A

Trial Description

Stroke patients who have little or no voluntary movement in the hand on the more affected side of their body more than one year after stroke have few treatment options. This project proposes to test the efficacy of a form of Constraint-Induced Movement therapy designed for patients with such severe impairment in conjunction with an agent, fluoxetine, which has been shown in some studies to enhance brain neuroplasticity in response to training. Constraint-Induced Movement therapy, which is abbreviated CIMT, is a form of physical rehabilitation based on basic research in neuroscience and behavioral science. If the project is successful, an efficacious, evidence-based therapy will become available to stroke patients for what is now a largely untreated condition

Trial Stopped: not funded

Conditions

Interventions

  • Fluoxetine (ProzacĀ®)Drug
    Other Names: Patients receiving fluoxetine
    ARM 1: Kind: Experimental
    Label: eCMIT and Fluoxetine
    Description: expanded form of Constraint Induced Movement Therapy (eCIMT) combined with Fluoxetine (FLX)
    ARM 2: Kind: Experimental
    Label: eCIMT and placebo
    Description: expanded form of Constraint Induced Movement Therapy (eCIMT) combined with placebo
    ARM 3: Kind: Experimental
    Label: Usual care and fluoxetine
    Description: Ususal physical care combined with Fluoxetine (FLX)
  • Placebo Drug
    ARM 1: Kind: Experimental
    Label: eCIMT and placebo
    Description: expanded form of Constraint Induced Movement Therapy (eCIMT) combined with placebo
    ARM 2: Kind: Experimental
    Label: Usual care and placebo
    Description: Usual physical care combined with placebo
  • Usual care Other
    ARM 1: Kind: Experimental
    Label: Usual care and fluoxetine
    Description: Ususal physical care combined with Fluoxetine (FLX)
    ARM 2: Kind: Experimental
    Label: Usual care and placebo
    Description: Usual physical care combined with placebo
  • ECMIT Procedure
    ARM 1: Kind: Experimental
    Label: eCMIT and Fluoxetine
    Description: expanded form of Constraint Induced Movement Therapy (eCIMT) combined with Fluoxetine (FLX)

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Grade 4/5 Motor Activity Log (MAL) Arm Use Scale baseline to 90 days No
Secondary Grade 4/5 MAL Arm Use scale baseline to 12 months after therapy No
Secondary Grade 4/5 Wolf Motor Function Test Performance Rate score baseline to 90 days No

Sponsors