None listed
Conditions
Brief summary
This randomised, double blind, sham-controlled trial aims to investigate whether non-invasive brain stimulation in the form of transcranial direct current stimulation (tDCS) can alter cortical neuro-excitability and thus enhance the effects of physical therapies in people with stroke. We hope to recruit 75 subjects who have had their first-ever ischemic stroke within the previous 12 months who have mild to moderate upper limb impairments. Subjects undergo 20 minutes of tDCS followed by 1 hour of robot-assisted arm therapy 2-3 times/week for 6-9 weeks (total 18 interventions). Outcome measures include neurophysiological, impairment, functional, psychological and subjective measures.
Interventions
Each participant will receive 18 sessions of treatment over 6-9 weeks (3days a week for 6 weeks or 2 days a week for 9 weeks depending on patients convenience) supervised one on one by a neuro-physiotherapist. Each treatment will comprise brain stimulation (real or sham tDCS) for 20 minutes followed by about 1 hour of robotic therapy. Transcranial direct current stimulation (tDCS) is a non-invasive technique that changes the excitability of brain cells by applying a weak direct current (1-2mA) to the brain. The method of applying tDCS involves placing saline-soaked sponge electrodes onto the skin of the scalp. These electrodes are connected to a battery driven direct current stimulator. tDCS is painless, inexpensive, has no major adverse effects and is easy to apply clinically. tDCS has been shown to improve arm function after stroke, with different montages of electrode placement over the affected and unaffected hemispheres (Kim et al. 2010; Hesse et al. 2011). In this study 2mA of anodal tDCS will be applied over the affected hemisphere for 20 minutes prior to arm therapy using the robot. The MITManus InMotion Shoulder-Elbow Robot will be used to provide shoulder and elbow movement training in the horizontal plane. The affected arm will be placed in an arm support trough and strapped in, with the hand grasped around a cone-shaped handle. This robot-arm is connected to a computer. All subjects will perform the same goal-directed activities to improve shoulder and elbow movements in different directions. The robot-arm detects the amount of movement that the subject can perform, and assists when they cannot reach the targets independently. The amount of assistance the robot-arm gives is constantly altered depending on the degree of movement from the subject.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Adults (>18 years old) with single first ever hemispheric ischaemic stroke verified by brain imaging, within the last 12 months 2. Moderate upper limb weakness and/or reduced function Fugl-Meyer upper limb score 25-52/66 3. Discharged from inpatient physiotherapy program 4. Previously independent (prior to stroke)
Exclusion criteria
1. Significant medical co-morbidities that would reduce exercise tolerance and rehabilitation potential such as heart failure, unstable angina, etc 2. Significant psychiatric co-morbidities, such as depression or anxiety 3. History of seizures, epilepsy or unexplained syncopal episodes 4. Cognitive impairment or receptive dysphasia (except if minimal) 5. Significant shoulder pain or arthritis, injury or fixed deformity of the affected limb 6. Presence of magnetically or electrically sensitive implants such as cardiac pacemakers, stimulators, pumps, cochlear implants, etc 7. To minimise potential risks, all participants will be thoroughly screened for tDCS/TMS risk factors twice: prior to enrolment and immediately prior to the experimental session