Post-stroke Neural Plasticity With Atomoxetine

Placebos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788357
• Other study ID #: No ID
• Status: Completed
• Phase: Phase 2
• First received: May 27, 2016
• Last updated: April 18, 2017
• Start date: November 2006
• Est. completion date: December 2014

Study information

• Verified date: April 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atomoxetine Hydrochloride
• Placebos

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lumy Sawaki

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fugl Meyer Assessment		Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
Secondary	Change in Action Arm Research Test (ARAT)		Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
Secondary	Change in Wolf Motor Function Test (WMFT)		Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
Secondary	Transcranial Magnetic Stimulation		Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline