Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03930121
Other study ID # DC-Train-Aphasia
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 6, 2019
Est. completion date August 4, 2025

Study information

Verified date May 2024
Source University Medicine Greifswald
Contact Agnes Floeel, Prof.
Phone +49 3834 86 6815
Email agnes.floeel@uni-greifswald.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

Intensive speech-language therapy (SLT) can promote recovery from chronic post-stroke aphasia, but effect sizes are moderate. This highlights the pressing need to explore adjunct strategies, such as transcranial direct current stimulation (tDCS), to enhance training effectiveness. Recently, the investigators provided evidence from a single-center randomized controlled trial (RCT) suggesting that anodal-tDCS of the left primary motor cortex (M1) improves naming and communication ability in chronic post-stroke aphasia, with medium-to-large effect sizes. However, prior to integration into clinical routine, a multi-center RCT with adequate power, duration, and outcomes relevant to everyday life is required, which is the goal of the present study. After trial completion, a workshop with relevant stakeholders will ensure transfer into best-practice guidelines.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date August 4, 2025
Est. primary completion date February 4, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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)

Locations

Country Name City State
Germany 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 BDH-Klinik Greifswald gGmbH Greifswald
Germany University medicine Greifswald, department of Neurology 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 Aphasie-Zentrum Vechta gGmbH Vechta

Sponsors (1)

Lead Sponsor Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in communication ability, as assessed by the Amsterdam Nijmegen Everyday Language Test 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. Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
Secondary Change in naming ability, as assessed based on personally relevant trained and untrained items, consistent with previous work (see description) Personally relevant trained and untrained items, consistent with previous work; cf. Meinzer M, Darkow R, Lindenberg R, et al. Electrical stimulation of the motor cortex enhances treatment outcome in post-stroke aphasia. Brain 2016; 139: 1152-1163. Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
Secondary Change in (non-)verbal communication, as assessed by the Scenario Test Scenario Test; cf. Nobis-Bosch R, Abel S, Krzok F, et al. Szenario Test-Testung verbaler und nonverbaler Aspekte aphasischer Kommunikation. ProLog, in preparation. Before the 3-week treatment period; 6-month follow-up
Secondary Change in (non-)verbal communication, as assessed by the Communicative Effectiveness Index Communicative Effectiveness Index; cf. Lomas J, Pickard L, Bester S, et al. The Communicative Effectiveness Index: development and psychometric evaluation of a functional communication measure for adult aphasia. J Speech Hear Disord 1989; 54: 113-124. Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
Secondary Change in attention and executive function, as assessed by the subscales Go/NoGo and Alertness from Test of Attentional Performance Subscales Go/NoGo and Alertness from Test of Attentional Performance; cf. Zimmermann P and Fimm B. Testbatterie zur Aufmerksamkeitsprüfung (TAP). Herzogenrath: PSYTEST Verlag, 2002. Before the 3-week treatment period; 6-month follow up
Secondary Change in non-verbal episodic memory, as assessed by the Figure Recognition Task from Benton Visual Retention Test Figure Recognition Task from Benton Visual Retention Test; cf. Benton Sivan A and Spreen O. Benton Test. Bern: Huber, 2009. Before the 3-week treatment period; 6-month follow up
Secondary Change in mood, as assessed by the German version of the 10-item Stroke Aphasic Depression Questionnaire German version of the 10-item Stroke Aphasic Depression Questionnaire (SADQH-10); cf. Cobley CS, Thomas SA, Lincoln NB, et al. The assessment of low mood in stroke patients with aphasia: reliability and validity of the 10-item Hospital version of the Stroke Aphasic Depression Questionnaire (SADQH-10). Clin Rehabil 2012; 26: 372-381. Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
Secondary Change in health-related quality of life, as assessed by the Stroke and Aphasia Quality of Life Scale Stroke and Aphasia Quality of Life Scale (SAQOL-39g); cf. Hilari K, Lamping DL, Smith SC, et al. Psychometric properties of the Stroke and Aphasia Quality of Life Scale (SAQOL-39) in a generic stroke population. Clin Rehabil 2009; 23: 544-557. Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
Secondary Change in health-related quality of life, as assessed by the EuroQol Health-Related Quality of Life Questionnaire EuroQol Health-Related Quality of Life Questionnaire (EQ-5D-5L); cf. EuroQol G. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199-208. Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
Secondary Change in direct and indirect costs during the 12-month study period, as assessed by the self-developed Patient Resource Consumption Questionnaire Direct and indirect costs during the 12-month study period, as determined by the self-developed Patient Resource Consumption Questionnaire considering common standardized unit cost assumptions. Before the 3-week treatment period; 6- and 12-month follow ups
Secondary Change in direct and indirect costs during the 12-month study period, as assessed by the Quality-Adjusted Life Years Quality-Adjusted Life Years; cf. Whitehead SJ and Ali S. Health outcomes in economic evaluation: the QALY and utilities. Br Med Bull 2010; 96: 5-21. Before the 3-week treatment period; 6- and 12-month follow ups
Secondary Change in unpaid support provided by family members or friends, as assessed by the Burden of informal caregivers Burden of informal caregivers; cf. van Exel NJ, Koopmanschap MA, van den Berg B, et al. Burden of informal caregiving for stroke patients. Identification of caregivers at risk of adverse health effects. Cerebrovasc Dis 2005; 19: 11-17. Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
See also
  Status Clinical Trial Phase
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Recruiting NCT03929432 - Treatment Outcomes With tDCS in Post-Stroke Aphasia N/A
Completed NCT03662295 - Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention
Completed NCT03679637 - Tablet-based Aphasia Therapy in the Acute Phase After Stroke N/A
Completed NCT03228264 - A Trial Investigating Telerehabilitation as an add-on to Face-to-face Speech and Language Therapy in Post-stroke Aphasia. N/A
Completed NCT03550092 - Analysis of Brain Activity to Uncover Brain-behavior Relationships Related to Therapy Outcomes in Aphasia N/A
Suspended NCT04290988 - Circuitry Assessment and Reinforcement Training Effects on Recovery N/A
Recruiting NCT05969548 - pBFS-guided cTBS at Different Doses for Aphasia After Stroke N/A
Recruiting NCT04138940 - Modulating Intensity and Dosage of Aphasia Scripts N/A
Terminated NCT02249819 - Evaluating Anodal tDCS Preceding Aphasia Therapy Phase 1/Phase 2
Completed NCT01654029 - Patient Centred Communication Intervention N/A
Completed NCT00843427 - fMRI of Language Recovery Following Stroke in Adults N/A
Active, not recruiting NCT00227461 - Levetiracetam (Keppra) to Improve Chronic Aphasia in Post-stroke Patients. Phase 1
Completed NCT03773419 - Improving Electronic Written Communication in Aphasia N/A
Not yet recruiting NCT04142866 - Transcranial Direct Current Stimulation (tDCS) With Verb Network Strengthening Treatment (VNeST) in Chronic Aphasia N/A
Suspended NCT04048668 - tDCS to Treat Subacute Aphasia N/A
Recruiting NCT04081207 - Using Augmentative & Alternative Communication to Promote Language Recovery for People With Post-Stroke Aphasia N/A
Completed NCT02226796 - Transcranial Direct Stimulation (tDCS) and Behavioral Intervention in Aphasia N/A
Completed NCT01163461 - Phonomotor Treatment of Word Retrieval Deficits in Individuals With Aphasia N/A