None listed
Conditions
Brief summary
Depression is a common and serious complication after stroke with extensive implications for mental health, functional recovery and health service utilisation (Hackett and Pickles, 2014). Pharmacological therapy has no clear effect on prevention or treatment of post-stroke depression (Hackett et al., 2008), suggesting alternative approaches are required. One novel intervention generating interest is non-invasive brain stimulation (NIBS), with studies reporting some beneficial effects of stimulating hypoactive frontal brain regions; the dorsolateral prefrontal cortex (DLPFC) (Shiozawa et al., 2014). However, few studies have been conducted in people with post-stroke depression so we do not know if this is a viable therapy. We primarily aim to investigate whether NIBS improves post-stroke depression in a pilot RCT
Interventions
Participants will be randomised to one of two study arms. The two arms will be high frequency rTMS to the dorsolateral prefrontal cortex (10 sessions over two weeks, week days only) or sham rTMS.
Stimulation will be delivered at 110% resting motor threshold, 10Hz, 3000 pulses once per day (approx 30 minutes). Ten sessions (over 2 weeks) will be delivered. The intervention will be delivered by a trained and experienced researcher in a university clinical trials facility.
Sponsors
University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Stroke (ischemic or hemorrhagic) Mild to severe depression as measured by the PHQ-9 score (5-27) No contraindications for rTMS no change in antidepressant medication for 6 months prior to treatment
Exclusion criteria
Unsafe for TMS
Outcome results
None listed