Post-stroke Neural Plasticity With Atomoxetine

NCT ID: NCT02788357

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2014-12-31

Brief 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.

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.

Conditions

Atomoxetine Hydrochloride; Placebos

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Atomoxetine with motor training

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

Group Type: EXPERIMENTAL

Atomoxetine

Intervention Type: DRUG

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 with motor training

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Strattera; Sham

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lumy Sawaki

OTHER

Sponsor Role: lead

Responsible Party

Lumy Sawaki

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

References

Ward A, Carrico C, Powell E, Westgate PM, Nichols L, Fleischer A, Sawaki L. Safety and improvement of movement function after stroke with atomoxetine: A pilot randomized trial. Restor Neurol Neurosci. 2017;35(1):1-10. doi: 10.3233/RNN-160673.

Reference Type: DERIVED

PMID: 27858723 (View on PubMed)

Other Identifiers

No ID

Identifier Type: -

Identifier Source: org_study_id