Phase 2
Completed N=24
Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
Source: ClinicalTrials.gov NCT00720759 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Mar 2014
Primary outcomePrimary: Wolf Motor Function Test (Time) — 10.21; 29.69; 19.09; 26.05 units on a scale — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wolf Motor Function Test (Time) |
10.21; 29.69; 19.09; 26.05 | <0.05 sig |
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.
Data sourced from ClinicalTrials.gov (NCT00720759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.