Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients
Condition: Stroke; Motor Function
MeSH terms: Stroke
Intervention: Active Repetitive Transcranial Magnetic Stimulation (rTMS); Fluoxetine; Sham repetitive transcranial magnetic stimulation (rTMS); Placebo Fluoxetine
Intervention description: Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.; Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.; Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered.; Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
Intervention MeSH terms: Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: repetitive transcranial magnetic stimulation; rTMS; TMS; fluoxetine

Summary:

      In this study investigator's aim to assess the effect of a type of non-invasive brain
      stimulation technique called repetitive transcranial magnetic stimulation (rTMS) in
      conjunction with fluoxetine on motor recovery after stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ischemic infarction within the past 2 years post event that has caused hemiparesis or
             hemiplegia, as self-reported and/or confirmed by medical record.

          -  Older than 18 years old.

          -  Upper extremity weakness defined as a score of >11 and ≤56 on the arm motor Fugl-Mayer
             motor scale.

          -  Minimal pre-stroke disability defined as a score of <3 in the Modified Rankin Scale.

          -  Subjects need to be able to follow directions and participate in 2 hours of testing
             with short breaks.

          -  Subjects need to be able to provide informed consent.

        Exclusion Criteria:

          -  Any substantial decrease in alertness, language reception, or attention that might
             interfere with understanding instruction for motor testing

          -  Excessive pain in any joint of the paretic extremity (not applicable to severe stroke
             subjects), as self reported

          -  Contraindications to single pulse TMS (will be used to measure cortical excitability)
             such as: history of seizures, unexplained loss of consciousness, any metal implants in
             the head, frequent or severe headaches or neck pain, any other electronic implanted
             medical devices such as pacemakers, defibrillators, or implant medication pump.

          -  Patients who have taken fluoxetine in the past 5 weeks.

          -  Patients taking any other SSRI at the time of enrollment or in the previous month.

          -  Patients taking any other medication likely to have adverse interaction with SSRIs
             (all the medications the patient is taking will be carefully reviewed, as noted below
             in "Monitoring of important drug interactions").

          -  Active depression on admission to SRH defined by a score of 24 or higher in the
             Hamilton Depression Rating Scale (HAM-D)

          -  Concurrent medical condition likely to worsen patient's functional status in the next
             6 months such as: cancer, terminal heart, kidney or liver disease, as self-reported
             and/or confirmed by medical record.

          -  Pregnancy.