Stroke
Conditions
Keywords
Rehabilitation, Non Invasive Brain Stimulation
Brief summary
Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS. Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.
Interventions
DEVICErTMS
Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.
DEVICESham
Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.
DEVICEtDCS
Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ischemic or hemorrhagic stroke (\> 6 months from the accident)
Exclusion criteria
* general cognitive impairment (Mini Mental State Examination \< 25), severe functional disability (Barthel Index \< 45), * psychiatric disorders, * degenerative neurological disorders, * epilepsy, * severe medical conditions, * having been implanted a drug infusion system, spinal/brain-stimulator, or endovascular coil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement) | Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months | Action Research Arm Test (ARAT) measures Grasp, Grip, Pinch, Gross Movement. Baseline is 1 week before first treatment; other time frame: 1 week after first treatment; 3 months after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 3 months follow-up after second treatment; 6 months follow-up after second treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| P300 (latency) | Baseline; 1 month; 6 months and 1 week; 7 months | The P300 (P3) wave is an event related potential (ERP) component elicited in the process of decision making. Investigators measured the latency of the component 1 week before first treatment; 1 week after first treatment; 1 week before second treatment; 1 week after second treatment. |
| Cognition (standardized neuropsychological assessment) | Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months | The patients were evaluated by means of a standardized neuropsychological assessment consisting of a battery of cognitive tests involving the following domains: verbal short-term memory, visuospatial learning, working memory, verbal learning, attention and frontal executive functions, and general cognitive impairment. The assessment was repeated 1 week before first treatment; 1 week after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 6 months follow-up after second treatment. |
Countries
Italy
Outcome results
None listed