Neuroregeneration Enhanced by Transcranial Direct Current Stimulation (TDCS) in Stroke

Universitätsklinikum Hamburg-Eppendorf119 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

119

Conditions

Stroke

Interventions

DC-Stimulator to apply tDCSDEVICE

Anodal tDCS (20 minutes) stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training

DC-Stimulator to apply Sham tDCSDEVICE

Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Neurologische Universitätsklinik Wien

Vienna, State of Vienna, Austria

Klinik Kipfenberg

Kipfenberg, Bavaria, Germany

Brandenburgklinik Berlin-Brandenburg

Bernau Bei Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

Upper Extremity Fugl-Meyer-Assessment (UEFMA)

standardized test of upper extremity function

Time frame: 1-7 days after the end of the intervention

Secondary Outcomes

Upper Extremity Fugl-Meyer-Assessment (UEFMA)

standardized test of upper extremity function

Time frame: 30±10 days after the intervention

Upper Extremity Fugl-Meyer-Assessment (UEFMA)

standardized test of upper extremity function

Time frame: 90±20 days after the intervention

Upper Extremity Fugl-Meyer-Assessment (UEFMA) | Long-term outcome

standardized test of upper extremity function

Time frame: 12±1 months after the intervention

Action Research Arm Test (ARAT)

standardized tests of upper extremity function

Time frame: 1-7 days after the end of the intervention

Action Research Arm Test (ARAT)

standardized tests of upper extremity function

Time frame: 30±10 days after the intervention

Action Research Arm Test (ARAT)

standardized tests of upper extremity function

Time frame: 90±20 days after the intervention

Action Research Arm Test (ARAT) | Long-term outcome

standardized tests of upper extremity function

Time frame: 12±1 months after the intervention

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.