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Post-stroke Neural Plasticity With Atomoxetine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02788357
First Posted: June 2, 2016
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lumy Sawaki, University of Kentucky
  Purpose
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.

Condition Intervention Phase
Atomoxetine Hydrochloride Placebos Drug: Atomoxetine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancement of Post-stroke Neural Plasticity With Atomoxetine: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Lumy Sawaki, University of Kentucky:

Primary Outcome Measures:
  • Change in Fugl Meyer Assessment [ Time Frame: 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.


Secondary Outcome Measures:
  • Change in Action Arm Research Test (ARAT) [ Time Frame: baseline, post-intervention, 1-month follow-up ]
    Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The score is calculated by summing the scores for 19 individual tasks. The possible scores range from 0 to 57, with higher scores indicating better performance.

  • Change in Wolf Motor Function Test (WMFT) [ Time Frame: baseline, post-intervention, 1-month follow-up ]
    Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.

  • Transcranial Magnetic Stimulation [ Time Frame: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline ]

Enrollment: 12
Study Start Date: November 2006
Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atomoxetine with motor training
40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays
Drug: Atomoxetine
Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
Other Name: Strattera
Placebo Comparator: Placebo with motor training
Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Drug: Placebo
Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
Other Name: Sham

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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°.

Exclusion Criteria:

  • 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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Lumy Sawaki, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02788357     History of Changes
Other Study ID Numbers: No ID
First Submitted: May 27, 2016
First Posted: June 2, 2016
Results First Submitted: June 15, 2017
Results First Posted: August 14, 2017
Last Update Posted: August 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lumy Sawaki, University of Kentucky:
motor training
motor recovery
human
neuroplasticity
transcranial magnetic stimulation

Additional relevant MeSH terms:
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs