Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)
Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy): Two daily sessions of intensive SLT combined with tDCS of the left primary motor cortex (M1)
Study summary
The aim of the study is to investigate whether intensive speech-language therapy (SLT) combined with anodal transcranial direct current stimulation (tDCS) leads to better communication performance than SLT combined with placebo stimulation (using sham-tDCS).
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* left-hemisphere cortical or subcortical stroke with first-ever aphasic symptoms
* at least 6 months post-onset of stroke;
* aphasia, as determined by the Aachen Aphasia Test (AAT);
* 13 moderate-to-severe word finding difficulties (maximum of 75% correct items on a computerized naming task at baseline);
* at least 1 correct reaction on the first part of the AAT subscale Token Test (ensuring basic comprehension skills);
* at least 1 point on the communicative task of the AAT subscale Spontaneous Speech (ensuring basic communication abilities);
* German as first language;
* intact left-hemisphere "hand knob" without right prefrontal lesions for placement of tDCS electrodes, as confirmed by magnetic resonance imaging or computer tomography scans.
Exclusion Criteria:
* contraindications for tDCS (e.g., cardiac pacemaker, history of seizures, implanted metal inside the head);
* more than one clinically apparent stroke with aphasic symptoms;
* other severe neurological diseases (e.g., brain tumor, and subdural hematoma);
* epilepsy with seizures during the last 12 months prior to study start and/or intake of sedating antiepileptic drugs (barbiturates and benzodiazepines),
* history of severe alcohol or drug abuse;
* current severe depression;
* current psychosis or other relevant psychiatric condition;
* very severe apraxia of speech, as revealed by Hierarchical Word Lists;
* severe non-verbal cognitive deficits, as indicated by the Corsi Block-Tapping Task;
* severe uncontrolled medical problems;
* severely impaired vision or hearing that prevents patients from engaging in intensive SLT;
* changes in centrally active drugs within 2 weeks prior to study inclusion.
Primary outcome measure(s)
Change in communication ability, as assessed by the Amsterdam Nijmegen Everyday Language Test — Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups Amsterdam Nijmegen Everyday Language Test (A-scale; parallel versions used in counterbalanced order across participants); cf. Blomert L, Kean ML, Koster C, et al. Amsterdam-Nijmegen Everyday Language Test-Construction, Reliability and Validity. Aphasiology 1994; 8: 381-407.
Trial sites (19)
Facility
City
Region
Status
Aphasiestation RWTH Aachen
Aachen
Germany
Kliniken Schmieder Allensbach
Allensbach
Germany
Schön Klinik Bad Aibling Harthausen
Bad Aibling
Germany
Wicker Klinik Bad Homburg
Bad Homburg
Germany
Moritz Kliniken Bad Klosterlausnitz
Bad Klosterlausnitz
Germany
Median Klinik Bad Sülze
Bad Sülze
Germany
ZAR Berlin
Berlin
Germany
Kliniken Schmieder Gailingen
Gailingen
Germany
Klinikum Christophsbad Göppingen
Göppingen
Germany
University Medicine Greifswald, Department of Neurology
Greifswald
Germany
BDH-Klinik Greifswald gGmbH
Greifswald
Germany
Kliniken Schmieder Heidelberg
Heidelberg
Germany
Hospital zum Heiligen Geist Kempen
Kempen
Germany
Tagesklinik MPI Leipzig
Leipzig
Germany
Logo Zentrum Lindlar
Lindlar
Germany
TheraVent aktiv Marbach
Marbach
Germany
St. Mauritius Therapieklinik
Meerbusch
Germany
EUFH Rostock
Rostock
Germany
Aphasie-Zentrum Vechta gGmbH
Vechta
Germany
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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