Stroke
Conditions
Keywords
stroke, non-invasive cortical stimulation, motor recovery, cortical plasticity, TDCS
Brief summary
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.
Detailed description
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.
Interventions
DEVICEDC-Stimulator to apply tDCS
Anodal tDCS (20 minutes) stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training
DEVICEDC-Stimulator to apply Sham tDCS
Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subacute stroke patients (5-45 days after stroke) with thromboembolic non-hemorrhagic subcortical or cortical, first clinically overt stroke will be included. Moderate to moderately severe upper-extremity hemiparesis, defined as an Upper Extremity Fugl-Meyer score (UEFMA) between 20 and 58 (inclusive).
Exclusion criteria
* pre-existing large lesions (\> 1.5 cm maximum diameter) in a brain area that belongs to the anatomically established sensorimotor/premotor system * progressive stroke * completely lesioned hand knob area of M1 affected if no motor evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) are present * bilateral motor impairment * florid alcohol and/or drug abuse * florid severe psychiatric illness (e.g. schizophrenia) * severe language disturbances that prevents the patient to give informed consent or inhibit adequate scoring because of insufficient understanding of scoring introductions * tumor diseases with a life expectancy less than one year * increased intracranial pressure * polyneuropathy and/or ischemic peripheral disease if the sensorimotor functions of the upper extremities are affected clinically relevant * severe cognitive deficits (MMSE ≤ 23) * pregnancy * contraindication for MRI or TMS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Fugl-Meyer-Assessment (UEFMA) | 1-7 days after the end of the intervention | standardized test of upper extremity function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Fugl-Meyer-Assessment (UEFMA) | Long-term outcome | 12±1 months after the intervention | standardized test of upper extremity function |
| Action Research Arm Test (ARAT) | 1-7 days after the end of the intervention | standardized tests of upper extremity function |
| Action Research Arm Test (ARAT) | Long-term outcome | 12±1 months after the intervention | standardized tests of upper extremity function |
| Nine Hole Peg Test (NHPT) | 1-7 days after the end of the intervention | standardized test to assess fine motor skills |
| Upper Extremity Fugl-Meyer-Assessment (UEFMA) | 30±10 days after the intervention | standardized test of upper extremity function |
| Stroke Impact Scale (SIS) | 1-7 days after the end of the intervention | questionnaire is to evaluate how stroke has impacted health and life of patients |
| Stroke Impact Scale (SIS) | Long-term outcome | 12±1 months after the intervention | questionnaire is to evaluate how stroke has impacted health and life of patients |
| Box-and-Block Test | 1-7 days after the end of the intervention | standardized test to assess fine motor skills |
| Grip Force | 1-7 days after the end of the intervention | dynamometer-based test to assess grip strength |
| Nine Hole Peg Test (NHPT) | Long-term outcome | 12±1 months after the intervention | standardized test to assess fine motor skills |
Countries
Austria, Germany, Italy
Outcome results
None listed