Neuroregeneration Enhanced by Transcranial Direct Current Stimulation (TDCS) in Stroke
- Conditions
- Stroke
- Interventions
- Device: DC-Stimulator to apply tDCSDevice: DC-Stimulator to apply Sham tDCS
- Registration Number
- NCT00909714
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anodal tDCS DC-Stimulator to apply tDCS Direct Current (DC)-Stimulator to apply tDCS + Training Sham tDCS DC-Stimulator to apply Sham tDCS Direct Current (DC)-Stimulator to apply Sham tDCS (Placebo) + Training
- Primary Outcome Measures
Name Time Method Upper Extremity Fugl-Meyer-Assessment (UEFMA) 1-7 days after the end of the intervention standardized test of upper extremity function
- Secondary Outcome Measures
Name Time Method 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) 90±20 days after the intervention standardized tests of upper extremity function
Grip Force 12±1 months after the intervention dynamometer-based test to assess grip strength
Upper Extremity Fugl-Meyer-Assessment (UEFMA) 90±20 days after the intervention standardized test of upper extremity function
Stroke Impact Scale (SIS) 90±20 days after the intervention questionnaire is to evaluate how stroke has impacted health and life of patients
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) 90±20 days after the intervention standardized test to assess fine motor skills
Nine Hole Peg Test (NHPT) | Long-term outcome 12±1 months after the intervention standardized test to assess fine motor skills
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 12±1 months after the intervention standardized test to assess fine motor skills
Trial Locations
- Locations (11)
University Medical Center Heidelberg
🇩🇪Heidelberg, Germany
MEDIAN Klinik Berlin-Kladow
🇩🇪Berlin, Germany
Neurologische Klinik Bad Aibling
🇩🇪Bad Aibling, Germany
University Medical Center Hamburg Eppendorf (UKE)
🇩🇪Hamburg, Germany
Neurologische Universitätsklinik Wien
🇦🇹Wien, Austria
Klinik Kipfenberg
🇩🇪Kipfenberg, Bayern, Germany
Brandenburgklinik Berlin-Brandenburg
🇩🇪Bernau bei Berlin, Berlin, Germany
Neurologisches Zentrum Segeberger Kliniken
🇩🇪Bad Segeberg, Germany
NRZ Leipzig
🇩🇪Bennewitz, Germany
Neurologie Moritzklinik
🇩🇪Bad Klosterlausnitz, Thüringen, Germany
Fondazione Santa Lucia
🇮🇹Rome, Italy