Effects of Bromocriptine on Aphasia Treatment Outcome

描述(申请人提供)：这项计划拨款的目的是开发临床试验的方法和方案，以评估药物制剂溴隐亭对非流利性失语症患者语言结果的有效性。有初步证据表明，溴隐亭(BRC)是一种多巴胺能药物，可以改善中风后失语症的特异性缺陷。然而，对它的研究主要是在慢性期，结果好坏参半。此外，大多数研究都使用溴隐亭作为单一疗法，但有证据表明，BRC如果与失语症语言治疗结合使用可能会更有效。需要精心设计的随机临床试验，并有足够的患者数量，以充分探索BRC治疗急性和慢性失语的最佳时机和持续时间，并评估BRC与言语-语言治疗相结合是否比其中任何一种单一治疗更有效。 因此，拟议的临床试验的具体目的是：(1)评估小剂量溴隐亭联合言语治疗是否比言语治疗加安慰剂对语言能力的改善更大；(2)评估小剂量溴隐亭的有效性是否因其结合言语和语言治疗的强度而不同；(3)评估语言能力的任何由此产生的变化是否会随着时间的推移而保持；以及(4)评估这些语言技能的维持是否依赖于持续使用溴隐亭。 两项随机、双盲、安慰剂对照试验(一项用于急性失语，一项用于慢性失语)被提出，每项试验包括以下四个方面：(1)BRC加低强度失语症治疗；(2)BRC加高强度失语症治疗；(3)BRC安慰剂加低强度失语症治疗；(4)BRC安慰剂加高强度失语症治疗。试验中每个比较的主要结果衡量标准将是西方失语症成套测验(Kertesz，1982)从治疗前到治疗后失语商(AQ)评分的变化。其他语言表现和认知测量将在治疗前和治疗后收集，以提供对语言表现变化的全面评估。还将在治疗结束后三个月和六个月测量语言表现，以回答有关保持语言进步的次要问题。

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.