Status:
COMPLETED
Neuroregeneration Enhanced by Transcranial Direct Current Stimulation (TDCS) in Stroke
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 f...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00909714
Start Date
July 1 2009
End Date
March 31 2021
Last Update
December 11 2024
Active Locations (11)
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1
Neurologische Universitätsklinik Wien
Vienna, Vienna, Austria, 1090
2
Klinik Kipfenberg
Kipfenberg, Bavaria, Germany, 85110
3
Brandenburgklinik Berlin-Brandenburg
Bernau Bei Berlin, State of Berlin, Germany, 16321
4
Neurologie Moritzklinik
Bad Klosterlausnitz, Thuringia, Germany, 07639