Clinical trial NCT02788357: Post-stroke Neural Plasticity With Atomoxetine
Official title: Enhancement of Post-stroke Neural Plasticity With Atomoxetine: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atomoxetine Hydrochloride
Placebos
Keywords: motor training
motor recovery
human
neuroplasticity
transcranial magnetic stimulation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Fugl Meyer Assessment
timeFrame: baseline, post-intervention, 1-month follow-up
Secondary outcomes:
measure: Change in Action Arm Research Test (ARAT)
timeFrame: baseline, post-intervention, 1-month follow-up
measure: Change in Wolf Motor Function Test (WMFT)
timeFrame: baseline, post-intervention, 1-month follow-up
measure: Transcranial Magnetic Stimulation
timeFrame: Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline
Other outcomes:
Locations:
Study officials:
References:
citation: 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.