Stroke, Hemiparesis
Conditions
Keywords
Stroke, Hemiparesis, tDCS, Motor cortex
Brief summary
The aim of the study is to investigate whether the combination of bihemispheric (dual) transcranial direct current stimulation (tDCS) and motor training on 5 consecutive days facilitates motor recovery in chronic stroke. Results will be compared to a matched group of patients undergoing anodal tDCS as well as a control group receiving sham tDCS. Functional and structural magnetic resonance imaging (MRI) before/after the intervention and during a 3 month follow-up will help investigating neural correlates of expected changes in motor function of the affected upper extremity.
Interventions
DEVICEtDCS
transcranial direct current stimulation (tDCS)
BEHAVIORALMotor training
Motor training of the affected upper extremity (5 days, 25 min/day).
Sponsors
Charite University, Berlin, Germany
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 80 Years
Healthy volunteers
No
Inclusion criteria
* chronic stroke (\>6 months after stroke) * age: 18 to 80 years * non-hemorrhagic or hemorrhagic stroke
Exclusion criteria
* more than 1 stroke * severe alcohol disease or drug abuse, severe psychiatric disease like depression or psychosis * severe cognitive deficits * severe untreated medical conditions * other neurologic diseases * severe microangiopathy * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Function of the Affected Upper Extremity | Change from baseline after 5 days (immediately after intervention) | Effects of dual tDCS + training vs sham-tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor Function of the Affected Upper Extremity | After 5 days (immediately after intervention), after 3 months vs baseline (before intervention) | Effects of dual tDCS + training vs anodal tDCS + training on the motor function of the affected upper extremity (measured by standardized behavioral tests). |
| Functional Magnetic Resonance Imaging | After 5 days (immediately after intervention), after 3 months vs baseline (before intervention) | Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on task-specific activations and functional connectivity (measured by functional Magnetic Resonance Imaging, fMRI). |
| Diffusion Tensor Imaging | After 5 days (immediately after intervention), after 3 months vs baseline (before intervention) | Effects of dual tDCS + training vs anodal tDCS + training vs sham-tDCS + training on cerebral microstructure (measured by Diffusion Tensor Imaging, DTI). |
| Transcranial Magnetic Stimulation | After 5 days vs baseline (before intervention) | Effects of dual tDCS + training vs anodal tDCS + training vs sham tDCS + training on excitability of the primary motor cortex (measured by Motor Evoked Potentials, MEP, using Transcranial Magnetic Stimulation, TMS). |
Countries
Germany
Outcome results
None listed