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Clinical Trials in Germany / NCT03930121
Active, not recruiting Not applicable

Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia

NCT03930121 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2019-12-06
Last updated
2025-05-16

Condition(s) studied

AphasiaPost-stroke

Investigational drug(s) / intervention(s)

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)

Trial sites (19)

FacilityCityRegionStatus
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

More University Medicine Greifswald trials in Germany

Official registry record

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.

View NCT03930121 on ClinicalTrials.gov ↗ ← All trials in Germany