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End of funds before obtaining the planned number of patients.
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| Name | Class |
|---|---|
| University Hospital, Geneva | OTHER |
| Clinique Romande de Readaptation | NETWORK |
| Ecole Polytechnique Fédérale de Lausanne | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal tDCS | Active Comparator | The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the contralesional supraorbital front of the patient. |
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| High definition (HD) anodal tDCS | Active Comparator | A single HD anode is placed over the primary motor cortex of the stroke affected hemisphere, 4 HD cathodes are placed over the affected hemisphere around the anode. |
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| Bihemispheric tDCS | Active Comparator | The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the primary motor cortex of the contralesional hemisphere. |
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| Sham tDCS | Sham Comparator | The electrodes are placed as in one of the active arms, but only a ramp up current is applied during 30 seconds and then switched off. This induces similar sensations for the patients, but no change in excitability. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-stimulator (Neuroconn, Germany) | Device | A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in upper extremity Fugl-Meyer score, after intervention | Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists | Difference between the week before the intervention and the week after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in EEG functional connectivity, 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. | Difference between the week before the intervention and the week after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in upper extremity Fugl-Meyer score, follow up 1 | Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists | Difference between the week before intervention and 4 weeks after intervention |
| Change in upper extremity Fugl-Meyer score, follow up 2 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian G Guggisberg, MD | University of Geneva, Switzerland | Principal Investigator |
| José Millán, PhD | University of Texas at Austin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Neurorehabilitation, University Hospital of Geneva | Geneva | Canton of Geneva | 1211 | Switzerland | ||
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Change in amplitude of motor evoked potentials, after intervention |
Motor evoked potentials are obtained with single-pulse transcranial magnetic stimulation. Continuous measure expressed in microvolts, more microvolts indicate better outcome. |
| 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 |
| Difference between the week before intervention and 12 weeks after stroke onset |
| Change in Jamar dynamometer, after intervention | Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists | Difference between the week before the intervention and the week after intervention |
| Change in Jamar dynamometer, follow up 1 | Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists | Difference between the week before intervention and 4 weeks after intervention |
| Change in Jamar dynamometer, follow up 2 | Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists | Difference between the week before intervention and 12 weeks after stroke onset |
| Change in Nine-Hole-Peg test, after intervention | Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists. | Difference between the week before the intervention and the week after intervention |
| Change in Nine-Hole-Peg test, follow up 1 | Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists. | Difference between the week before intervention and 4 weeks after intervention |
| Change in Nine-Hole-Peg test, follow up 2 | Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists. | Difference between the week before intervention and 12 weeks after stroke onset |
| Change in action research arm test (ARAT) score, after intervention | Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists | Difference between the week before the intervention and the week after intervention |
| Change in action research arm test (ARAT) score, follow up 1 | Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists | Difference between the week before intervention and 4 weeks after intervention |
| Change in action research arm test (ARAT) score, follow up 2 | Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists | Difference between the week before intervention and 12 weeks after stroke onset |
| Change in Functional Independence Measure (FIM) score, after intervention | Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses. | Difference between the week before the intervention and the week after intervention |
| Change in Functional Independence Measure (FIM) score, follow up 1 | Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses. | Difference between the week before intervention and 4 weeks after intervention |
| Change in Functional Independence Measure (FIM) score, follow up 2 | Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses. | Difference between the week before intervention and 12 weeks after stroke onset |
| Universitäre Neurorehabilitation, Inselspital |
| Bern |
| 3010 |
| Switzerland |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |