Effects of Bromocriptine on Aphasia Treatment Outcome

描述（由申请人提供）：该计划补助金的目的是开发临床试验的方法和方案，以评估药物溴隐亭对非流利性失语症患者语言结局的有效性。有初步证据表明，溴隐亭（BRC），多巴胺能药物，可以改善特定的缺陷失语症后中风。然而，它主要是在慢性阶段进行研究，结果好坏参半。此外，大多数研究使用溴隐亭作为单一疗法，但有证据表明，如果与失语症语言治疗联合使用，BRC可能更有效。需要精心设计的随机临床试验，有足够数量的患者，以充分探索BRC的最佳时机和持续时间的急性和慢性失语症，并评估是否BRC与语音语言治疗的组合是更有效的比他们中的任何一个作为单一疗法。 因此，拟议的临床试验的具体目的是：（1）评估低剂量溴隐亭联合语言治疗是否比语言治疗加安慰剂更能改善语言表现;（2）评估低剂量溴隐亭的有效性是否因联合使用的语言治疗强度而异;（3）评估语言表现的任何结果变化是否随时间保持;和（4）评估这些语言技能的保持是否依赖于持续使用溴隐亭。 拟定了两项随机双盲安慰剂对照试验（一项针对急性失语症，一项针对慢性失语症），每项试验均包含以下四个组：（1）BRC+低强度失语症治疗;（2）BRC+高强度失语症治疗;（3）BRC安慰剂+低强度失语症治疗;（4）BRC安慰剂+高强度失语症治疗。试验中每次比较的主要结局指标是西方失语症成套测验（Kertesz，1982）中失语商（AQ）评分从治疗前到治疗后的变化。将在治疗前和治疗后收集其他语言表现和认知指标，以全面评估语言表现的变化。还将在治疗完成后3个月和6个月测量语言表现，以回答关于保持语言改善的次要问题。

DESCRIPTION (provided by applicant): The purpose of this planning grant is to develop the methods and protocols for clinical trials that will evaluate the effectiveness of the pharmacological agent, bromocriptine, on the language outcome of patients with nonfluent aphasia. There is preliminary evidence that bromocriptine (BRC), a dopaminergic agent, can improve specific deficits of aphasia following stroke. However, it has been studied mostly in the chronic phases, and results have been mixed. Furthermore, most studies have used bromocriptine as a monotherapy but there is evidence that BRC may be more effective if given in combination with aphasia language treatment. Carefully designed randomized clinical trials with adequate numbers of patients are needed to adequately explore the optimum timing and duration of BRC for both acute and chronic aphasia, and to assess whether the combination of BRC with speech-language treatment is more effective than either one of them given as a monotherapy. Accordingly, the specific aims of the proposed clinical trials are (1) to assess whether low dose bromocriptine in combination with speech-language treatment results in greater improvements in language performance than speech-language treatment plus placebo; (2) to assess whether the effectiveness of low dose bromocriptine differs depending on the intensity of the speech-and-language treatment with which it is combined; (3) to assess whether any resultant changes in language performance are maintained over time; and (4) to assess whether the maintenance of these language skills is dependent on continued use of bromocriptine. Two randomized double-blind placebo-controlled trials (one for acute and one for chronic aphasia) are proposed, each with the following four arms (1) BRC plus low intensity aphasia treatment; (2) BRC plus high intensity aphasia treatment; (3) BRC placebo plus low intensity aphasia treatment; and (4) BRC placebo plus high intensity aphasia treatment. The primary outcome measure for each comparison in the trials will be the change in the Aphasia Quotient (AQ) score on the Western Aphasia Battery (Kertesz, 1982) from pretreatment to post-treatment. Other language performance and cognitive measures will be collected pre- and post-treatment to provide a comprehensive assessment of the changes in language performance. Language performance will also be measured at three and six months after completion of treatment to answer the secondary questions regarding maintenance of language improvements.