None listed
Conditions
Brief summary
Stroke is a leading cause of adult disability. Movement is commonly affected by stroke, and recovery of movement is important for regaining independence. However, there are currently no medical treatments available to promote recovery of movement. Fluoxetine is a commonly prescribed anti-depressant that might also be able to improve recovery of movement after stroke. However, it's not clear which patients are most likely to benefit from fluoxetine treatment. This project will selectively recruit patients who are predicted to have poor upper limb recovery, using a biomarker that tests the function of a key movement pathway in the brain. These patients will be randomised to receive fluoxetine or a placebo, in order to identify if fluoxetine will be a beneficial treatment for improving recovery of upper limb movement specifically in this more severe stroke population. It will also explore the neurobiological mechanisms of fluoxetine's effects, to better understand its possible benefits. The results will support the potential translation of fluoxetine into stroke rehabilitation clinical practice, to improve recovery and quality of life for people with more severe upper limb impairment after stroke.
Interventions
Participants will be instructed to orally ingest fluoxetine in the form of 1 x 20 mg capsule, daily for 90 days, starting within 10 days of stroke symptom onset.
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
At least 18 years old Monohemispheric cerebral ischaemic or haemorrhagic stroke Stroke symptom onset in the previous 10 days Moderate to severe upper limb motor impairment on day 3 post-stroke, defined as a Shoulder Abduction, Finger extension (SAFE) score <5 out of 10 and upper limb Fugl-Meyer (UE-FM) score <20. Patients must not have motor evoked potentials (be MEP-) when tested with transcranial magnetic stimulation (TMS) between 3 and 7 days after stroke. Patients treated with intravenous thrombolysis and/or intra-arterial thrombectomy are eligible. Patients with previous ischaemic or haemorrhagic stroke are eligible.
Exclusion criteria
Contraindications to fluoxetine, including: hepatic impairment, renal impairment, and hyponatraemia, as assessed by the study physician. Contraindications to TMS and evaluated using a safety screening checklist, including biomedical implant devices, history of seizures or medications increasing seizure risk, and pregnancy Unable to safely swallow capsules, as determined by the patient’s clinical team Cognition and/or communication impairment precluding informed consent or compliance with the research procedures, as determined by the patient’s clinical team Life expectancy less than 12 months, as determined by the patient’s clinical team Upper limb motor performance limited by pre-existing conditions, such as musculoskeletal disease Concurrent diagnosis of depression Any anti-depressant usage in the month prior to stroke Residing out of region precluding follow-up. Need for an interpreter
Outcome results
None listed