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临床试验/NCT02788357
NCT02788357已完成2 期

Enhancement of Post-stroke Neural Plasticity With Atomoxetine: a Pilot Study

Lumy Sawaki0 个研究点目标入组 12 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
12
主要终点
Change in Fugl Meyer Assessment

研究概览

简要总结

This proposal evaluates the safety and effectiveness of a noradrenergic drug named atomoxetine combined with motor training to enhance cortical plasticity and improve hand function after stroke.

详细描述

Extensive studies in laboratory animals and humans over the last ten years indicate that some medications, especially amphetamine, given with specific physical therapy may improve motor learning (and therefore recovery from stroke) more than physical therapy alone. However, the number of patients in clinical trials who have received physical therapy and amphetamine is very small, for two reasons: because amphetamine may interact with many other medications that stroke patients are already taking, and because its potential for addiction precludes its use on a daily basis. The investigators now wish to evaluate the effectiveness of a more selective medication, atomoxetine, known to have many fewer side effects and no potential for drug addiction. The proposed mechanism by which amphetamine enhances recovery is by increasing central levels of norepinephrine. While the investigators already know that this drug is more selective than amphetamine, the investigators would like to evaluate its effects on hand motor learning and motor recovery in chronic stroke patients in a clinical setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic stroke patients
  • Single stroke
  • Chronic (more than 6 months after from stroke)
  • At least 21 years old, but there is no upper age range for this project.
  • Participants NOT able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.

排除标准

  • History of head injury with loss of consciousness
  • History of severe alcohol or drug abuse
  • History of psychiatric illness
  • Unstable cardiac dysrhythmia
  • High blood pressure (systolic pressure >160 mm Hg and/or diastolic pressure >100 mm Hg)
  • History of myocardial infarction or unstable angina
  • Pregnancy
  • Glaucoma, history of hypersensitivity or idiosyncrasy to sympathomimetic drugs.
  • Subjects using drugs suspected of interfering with plasticity, such as MAOI, alpha-adrenergic antagonists, benzodiazepines, muscarinic receptor antagonists, dopaminergic antagonists, or other neuroleptics within 3 months of recruitment.

研究组 & 干预措施

Atomoxetine with motor training

Experimental

40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays

干预措施: Atomoxetine (Drug)

Placebo with motor training

Placebo Comparator

Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays

干预措施: Placebo (Drug)

结局指标

主要结局

Change in Fugl Meyer Assessment

时间窗: baseline, post-intervention, 1-month follow-up

Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.

次要结局

  • Change in Action Arm Research Test (ARAT)(baseline, post-intervention, 1-month follow-up)
  • Change in Wolf Motor Function Test (WMFT)(baseline, post-intervention, 1-month follow-up)
  • Transcranial Magnetic Stimulation(Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline)

研究者

发起方
Lumy Sawaki
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lumy Sawaki

Associate Professor

University of Kentucky

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