Stroke
Conditions
Keywords
stroke, brain stimulation, electroencephalography, functional magnetic resonance imaging, functional connectivity
Brief summary
Background: Stroke is a leading cause of adult disability. Non-invasive brain stimulation can induce significant and sustained improvements in functional outcome. However the effect is inconsistent and difficult to predict, in particular in the subacute phase after stroke. Although several different stimulation techniques are available, it is unknown which is suitable for which patient. Objectives: This study has three main objectives: 1. To compare the effects of two techniques of non-invasive brain stimulation (cTBC, continuous theta-burst stimulation; tDCS, direct current transcranial stimulation) on clinical recovery in patients with subacute stroke. 2. To assess the effect of these brain stimulation techniques on brain organization with non-invasive imaging. 3. To find clinical and neural predictors of responsiveness to brain stimulation therapy. Method: 45 patients with ischemic or hemorrhagic stroke will be randomly assigned to one of 3 groups: cTBS, tDCS, or sham stimulation. Each group will receive the corresponding stimulation therapy 3 times per week for 3 weeks, immediately before intensive physical therapy. Before and after the treatment period, standardized assessments of sensorimotor function areas are obtained together with electroencephalography and functional magnetic resonance recordings. These recordings will be used to analyze and compare the neural effects of each treatment modality. Clinical Implication: The results of this study might help optimize and individualize stimulation treatment for patients with subacute stroke. It may hence facilitate the transfer of brain stimulation therapy to routine clinical practice.
Interventions
Sponsors
Swiss National Science Foundation
Adrian Guggisberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ischemic or hemorrhagic stroke leading to unilateral deficits in motor function with significant impact on independence and daily activities at the beginning of rehabilitation * less than 10 weeks after stroke onset.
Exclusion criteria
* epileptic seizures * metallic objects in the brain * presence of implants or neural stimulators * pregnancy * sleep deprivation * recent traumatic brain injury * delirium or disturbed vigilance * inability to participate in 1h treatment sessions * severe language comprehension deficits * skull breach * new stroke lesions during rehabilitation * medical complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in compound motor score slope at week 4 | week 4 after treatment start | The Fugl Meyer motor assessment (FMA), the Nine Hole Peg test (expressed as pegs per minute), and the Jamar dynamometer strength of the affected arm are normalized to the healthy arm and averaged to a compound motor score. This score is obtained twice before treatment (at weeks -1 and 0 relative to treatment start), and twice after treatment (at weeks 4 and 8). Primary outcome measure is the change in slope from week 0 to 4 as compared to the slope between week -1 and 0. |
| Change in alpha-band coherence between the affected motor cortex and the rest of the brain | Week 4 | Calculated from electroencephalography recordings |
Secondary
| Measure | Time frame |
|---|---|
| Change in alpha-band coherence between the unaffected motor cortex and the rest of the brain | Week 4 |
| Change in Fugl Meyer Upper Extremity Motor Score at week 4 | Week 4 |
| Number of adverse events | Week 4 |
| Change in activity of daily life scale (motor activity log, MAL) | Week 4 |
| Change in Fugl Meyer Upper Extremity Motor Score at week 8 | Week 8 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in average velocity in the Nine Hole Peg test at week 8 | Week 8 | expressed in pegs/sec |
| Correlation between change in alpha band coherence and clinical improvements | Week 4 | Alpha band coherence is calculated from electroencephalography (EEG) recordings |
| Change in Jamar Dynamometer strength at week 4 | Week 4 | — |
| Change in correlations of spontaneous fMRI fluctuations within the motor network | Week 4 | Calculated from functional magnetic resonance (fMRI) recordings |
| Change in fractional anisotropy of the affected cortico-spinal tract | Week 4 | Calculated from diffusion tensor imaging (DTI) sequences of magnetic |
| Change in Jamar Dynamometer strength at week 8 | Week 8 | — |
| Change in Score of the Box and Block test, week 4 | Week 4 | — |
| Change in Score of the Box and Block test, week 8 | week 8 | — |
| Total Fugl Meyer motor assessment score at week 4 | Week 4 | — |
| Total Fugl Meyer motor assessment score at week 8 | Week 8 | — |
| Change in average velocity in the Nine Hole Peg test at week 4 | Week 4 | expressed in pegs/sec |
Countries
Switzerland
Outcome results
None listed