Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
关键词
抽象
描述
Each year, 730,000 Americans experience a stroke. Forty percent are left with persistent impairment of upper extremity function. Although scientifically vetted rehabilitation therapies for this impairment are starting to emerge, current treatment is generally unsatisfactory. Therapies that seek to engage neuroplastic mechanisms constitute one approach to this problem. A good example is constraint induced movement therapy (CIMT), a treatment that seeks, through extensive functional task practice, to overcome an acquired intentional predisposition to use the spared arm (learned non-use), and to improve motor function in the affected arm. CIMT has been tested in a host of trials, most recently a multicenter randomized controlled trial (RCT) - the EXCITE trial. These trials have generally demonstrated that on average, the treatment shows efficacy, and the results from the RCT indicate that it is more efficacious than "standard" therapies. However, problems with CIMT can be readily identified that pose research challenges: 1) on average, efficacy is limited; 2) only a fraction of subjects show substantial benefit. We propose to address these two problems in a pilot RCT of 20 subjects that will test two modifications of standard CIMT: 1) addition of a drug, d-cycloserine, that may enhance neuroplasticity by potentiating NMDA-glutamate receptor-mediated learning mechanisms; 2) delivery of a fixed amount of CIMT over a greater number of days, which according to learning research, may enhance long-term retention of gains.
All subjects in this trial will receive CIMT. Subjects will be randomized to one of 4 groups:
A. CIMT + d-cycloserine, more condensed treatment B. CIMT + d-cycloserine, less condensed treatment C. CIMT + placebo, more condensed treatment D. CIMT + placebo, less condensed treatment The primary outcome measure will be performance on the Wolf Motor Function Test (time) 3 months after completion of treatment.
日期
最后验证: | 12/31/2013 |
首次提交: | 07/20/2008 |
提交的预估入学人数: | 07/21/2008 |
首次发布: | 07/22/2008 |
上次提交的更新: | 01/20/2014 |
最近更新发布: | 03/06/2014 |
首次提交结果的日期: | 10/06/2013 |
首次提交质量检查结果的日期: | 01/20/2014 |
首次发布结果的日期: | 03/06/2014 |
实际学习开始日期: | 06/30/2009 |
预计主要完成日期: | 10/31/2011 |
预计完成日期: | 10/31/2011 |
状况或疾病
干预/治疗
Drug: Arm 1
Behavioral: Arm 2
Drug: Arm 3
Behavioral: Arm 4
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Arm 1 D-cycloserine + distributed treatment | Drug: Arm 1 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 |
Sham Comparator: Arm 2 D-cycloserine + condensed treatment | Behavioral: Arm 2 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 |
Placebo Comparator: Arm 3 Placebo + distributed treatment | Drug: Arm 3 Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session |
Placebo Comparator: Arm 4 Placebo + condensed treatment | Behavioral: Arm 4 Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session |
资格标准
有资格学习的年龄 | 20 Years 至 20 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | 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. |
结果
主要结果指标
1. Wolf Motor Function Test (Time) [3 months after completion of treatment]