Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
Condition: Stroke
MeSH terms: Stroke
Intervention: D-cycloserine + distributed treatment; D-cycloserine + condensed treatment; Placebo + distributed treatment; Placebo + condensed treatment
Intervention description: Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session; Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session; Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session; Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: stroke; hemiparesis; randomized controlled trial; d-cycloserine; distributed practice; constraint induced movement therapy

Summary:

      Each year 730,000 Americans experience a stroke. Forty percent are left with significant
      paralysis of one arm. Certain types of physical therapy, for example constraint induced
      movement therapy (CIMT), have been shown to be effective in improving arm function. However,
      for most subjects, improvement is modest. In this trial, we test two approaches that may
      increase the amount of improvement achieved: 1) distributing treatment over a greater amount
      of time; and 2) adding a drug, d-cycloserine, which theoretically enhances the molecular
      mechanisms of learning.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 21-80,

          -  of either sex,

          -  diverse ethnic background,

          -  s/p a single unilateral hemispheric stroke 6 or more months prior,

          -  who meet upper extremity functional criteria for participation in constraint induced
             movement therapy.

        Exclusion Criteria:

          -  History of more than minor head trauma,

          -  subarachnoid hemorrhage,

          -  dementia or other neurodegenerative disease,

          -  multiple sclerosis,

          -  lobar intracerebral hemorrhage,

          -  epilepsy,

          -  drug or alcohol abuse,

          -  serious medical illness,

          -  serum creatinine >1.5,

          -  schizophrenia,

          -  major refractory depression,

          -  insufficient cardiopulmonary function to participate in low-intensity,

          -  sustained upper extremity exercise,

          -  severe visual impairment,

          -  pregnancy,

          -  inability to understand the potential risks and benefits of the study,

          -  personally provide informed consent, and

          -  understand and cooperate with treatment.