Stroke
Conditions
Brief summary
Neurological deficits and motor disorders are extremely common after stroke. Physical therapies can improve the autonomy of these patients, but despite an intensive stationary neurorehabilitation, severe deficits often persist. Complementary therapies that could improve recovery would therefore be very welcome. Transcranial direct current stimulation (tDCS) induces, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of certain cerebral regions. An increasing number of studies show that this modulation of brain activity can improve motor functions in patients with brain lesions and increase the effect of physical therapies. However, the optimum configuration of tDCS and the induced effects remain to be characterized and investigated. The investigators therefore propose to carry out a study including a pilot phase in order to determine the most efficient tDCS setup. The optimum setup of of the pilot phase will be compared to a placebo condition in a multicentric main study.
Interventions
DEVICEDC-stimulator (Neuroconn, Germany)
A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.
Sponsors
University Hospital, Geneva
Clinique Romande de Readaptation
Ecole Polytechnique Fédérale de Lausanne
Adrian Guggisberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ischemic or hemorrhagic stroke * ≤ 4 weeks after stroke onset * Paresis of upper limb with Fugl-Meyer score between 15 and 55 at study entry * Capable of participating during treatment sessions of 30-60 minutes * Informed consent obtained
Exclusion criteria
* Incapacity to understand study information or task instructions during trial. * New additional stroke during rehabilitation * Reduced vigilance or delirium * Severe language deficits * Preexisting affection of an upper limb * Severe spasticity or dystonia * Severe co-morbidities (e.g., traumatic, rheumatologic, neurodegenerative disease) * Pregnancy * Pacemaker * Skull breach * History of seizures or epilepsy * Metallic object in the brain * Other contraindication to non-invasive brain stimulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in upper extremity Fugl-Meyer score, after intervention | Difference between the week before the intervention and the week after intervention | Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in EEG functional connectivity, after intervention | Difference between the week before the intervention and the week after intervention | EEG functional connectivity between ipsilesional motor cortex and the rest of the brain, as computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome. |
| Change in amplitude of motor evoked potentials, after intervention | Difference between the week before the intervention and the week after intervention | Motor evoked potentials are obtained with single-pulse transcranial magnetic stimulation. Continuous measure expressed in microvolts, more microvolts indicate better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Jamar dynamometer, follow up 1 | Difference between the week before intervention and 4 weeks after intervention | Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists |
| Change in Jamar dynamometer, follow up 2 | Difference between the week before intervention and 12 weeks after stroke onset | Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists |
| Change in Nine-Hole-Peg test, after intervention | Difference between the week before the intervention and the week after intervention | Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists. |
| Change in Nine-Hole-Peg test, follow up 1 | Difference between the week before intervention and 4 weeks after intervention | Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists. |
| Change in Nine-Hole-Peg test, follow up 2 | Difference between the week before intervention and 12 weeks after stroke onset | Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists. |
| Change in upper extremity Fugl-Meyer score, follow up 1 | Difference between the week before intervention and 4 weeks after intervention | Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists |
| Change in action research arm test (ARAT) score, follow up 1 | Difference between the week before intervention and 4 weeks after intervention | Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists |
| Change in action research arm test (ARAT) score, follow up 2 | Difference between the week before intervention and 12 weeks after stroke onset | Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists |
| Change in Functional Independence Measure (FIM) score, after intervention | Difference between the week before the intervention and the week after intervention | Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses. |
| Change in Functional Independence Measure (FIM) score, follow up 1 | Difference between the week before intervention and 4 weeks after intervention | Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses. |
| Change in Functional Independence Measure (FIM) score, follow up 2 | Difference between the week before intervention and 12 weeks after stroke onset | Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses. |
| Change in action research arm test (ARAT) score, after intervention | Difference between the week before the intervention and the week after intervention | Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists |
| Change in upper extremity Fugl-Meyer score, follow up 2 | Difference between the week before intervention and 12 weeks after stroke onset | Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists |
| Change in Jamar dynamometer, after intervention | Difference between the week before the intervention and the week after intervention | Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists |
Countries
Switzerland
Outcome results
None listed