Post-stroke Neural Plasticity With Atomoxetine

Lumy Sawaki

Status and phase

Completed

Phase 2

Conditions

Atomoxetine Hydrochloride

Placebos

Treatments

Drug: Atomoxetine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02788357

No ID

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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.