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rTMS and Fluoxetine for Motor Recovery in Stroke
NCT02208466Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2014
- Primary completion
- Jun 2019
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- fluoxetine
- Conditions
- ischemic stroke
01
Overview
Phase 2, randomised, double-blind trial of fluoxetine in ischemic stroke (3 arms), sponsored by Spaulding Rehabilitation Hospital. Primary endpoints: Changes in Motor Function (Jebsen-Taylor Task) at 90 days and Changes in Fugl-Meyer Assessment Scale at 90 days. Started Sep 2014; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Active rTMS + Fluoxetine
Active rTMS sessions + Active Fluoxetine 20mg daily
Sham rTMS + Fluoxetine
Sham rTMS sessions + Active Fluoxetine 20mg daily
Sham rTMS + Placebo
Sham rTMS sessions + Placebo Fluoxetine daily
03
Who it enrols
Adult patients with ischemic infarction within the past 2 years causing hemiparesis or hemiplegia, with upper extremity weakness (Fugl-Mayer 11-56) and minimal pre-stroke disability. Patients with depression, seizures, metal implants, or recent SSRI use are excluded.
04
Endpoints
Primary
Changes in Motor Function (Jebsen-Taylor Task)
Changes in Fugl-Meyer Assessment Scale
Secondary
Changes in Cortical Excitability Measures
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