DC-Stimulator to apply tDCS
DeviceAnodal tDCS (20 minutes) stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training
NCT Number: NCT00909714
Testing the hypothesis that non-invasive brain stimulation by transcranial direct current stimulation (tDCS) combined with functional training in the subacute phase of first-ever stroke will enhance functional regeneration compared with a Placebo intervention.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Neurologische Universitätsklinik Wien, Vienna, State of Vienna, Austria
Stroke is the leading cause of long-term disability, which significantly impairs the economic and social life of patients and society. Every year 200 000 to 250 000 patients suffer a stroke in Germany. Only a small number of the stroke survivors recover to a degree that allows them to return into their professional and private life. Despite significant efforts to develop novel and efficient treatment strategies the level of functional regeneration is still not satisfying. Thus, the development of innovative and effective treatment strategies will have a major impact for the patients' life, the society and the public health system.
Within the proposed project an innovative, non-invasive and cost effective interventional strategy, based on the combination of a specific rehabilitative training and brain stimulation by transcranial direct current stimulation (tDCS), will be used to enhance functional regeneration in stroke patients. The intervention will be applied in an early stage in which plasticity, cortical reorganization and functional improvement is most pronounced. We hypothesize that the combination of anodal tDCS delivered to the motor cortex of the affected hemisphere combined with training over a period of two weeks in the subacute stage after stroke will significantly enhance cortical plasticity, functional regeneration and long-term outcome determined by clinical and functional outcome measures compared with Placebo stimulation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Anodal tDCS (20 minutes) stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training
Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training
Time frame: 1-7 days after the end of the intervention
standardized test of upper extremity function
Time frame: 30±10 days after the intervention
standardized test of upper extremity function
Time frame: 90±20 days after the intervention
standardized test of upper extremity function
Time frame: 12±1 months after the intervention
standardized test of upper extremity function
Time frame: 1-7 days after the end of the intervention
standardized tests of upper extremity function
Time frame: 30±10 days after the intervention
standardized tests of upper extremity function
Time frame: 90±20 days after the intervention
standardized tests of upper extremity function
Time frame: 12±1 months after the intervention
standardized tests of upper extremity function
Time frame: 1-7 days after the end of the intervention
standardized test to assess fine motor skills
Time frame: 30±10 days after the intervention
standardized test to assess fine motor skills
Time frame: 90±20 days after the intervention
standardized test to assess fine motor skills
Time frame: 12±1 months after the intervention
standardized test to assess fine motor skills
Time frame: 1-7 days after the end of the intervention
questionnaire is to evaluate how stroke has impacted health and life of patients
Time frame: 30±10 days after the intervention
questionnaire is to evaluate how stroke has impacted health and life of patients
Time frame: 90±20 days after the intervention
questionnaire is to evaluate how stroke has impacted health and life of patients
Time frame: 12±1 months after the intervention
questionnaire is to evaluate how stroke has impacted health and life of patients
Time frame: 1-7 days after the end of the intervention
standardized test to assess fine motor skills
Time frame: 30±10 days after the intervention
standardized test to assess fine motor skills
Time frame: 90±20 days after the intervention
standardized test to assess fine motor skills
Time frame: 12±1 months after the intervention
standardized test to assess fine motor skills
Time frame: 1-7 days after the end of the intervention
dynamometer-based test to assess grip strength
Time frame: 30±10 days after the intervention
dynamometer-based test to assess grip strength
Time frame: 90±20 days after the intervention
dynamometer-based test to assess grip strength
Time frame: 12±1 months after the intervention
dynamometer-based test to assess grip strength
Universitätsklinikum Hamburg-Eppendorf
Other
Neuroregeneration Enhanced by TDCS in Stroke
Acronym: NETS
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