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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy) |
|
| Control group | Sham Comparator | Placebo stimulation (using sham-tDCS) combined with SLT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy) | Other | Two daily sessions of intensive SLT combined with tDCS of the left primary motor cortex (M1) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnes Floeel, Prof. | University Medicine Greifswald | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aphasiestation RWTH Aachen | Aachen | 52074 | Germany | |||
| Kliniken Schmieder Allensbach |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38175228 | Derived | Unger N, Stahl B, Darkow R, Scholz V, Weinmar I, Schmidt J, Breitenstein C, Meinzer M, Grewe T, Floel A. [Transcranial direct current stimulation to enhance training effectiveness in chronic poststroke aphasia-A challenge for recruiting participants]. Nervenarzt. 2024 Apr;95(4):368-375. doi: 10.1007/s00115-023-01572-7. Epub 2024 Jan 4. German. | |
| 31695667 |
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Two daily sessions of intensive speech-language therapy combined with transcranial direct current stimulation of the left primary motor cortex (M1)
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Allensbach |
| 78476 |
| Germany |
| Schön Klinik Bad Aibling Harthausen | Bad Aibling | 83209 | Germany |
| Wicker Klinik Bad Homburg | Bad Homburg | 61348 | Germany |
| Moritz Kliniken Bad Klosterlausnitz | Bad Klosterlausnitz | 07639 | Germany |
| Median Klinik Bad Sülze | Bad Sülze | 18334 | Germany |
| ZAR Berlin | Berlin | 10115 | Germany |
| Kliniken Schmieder Gailingen | Gailingen | 78262 | Germany |
| Klinikum Christophsbad Göppingen | Göppingen | 73035 | Germany |
| University Medicine Greifswald, Department of Neurology | Greifswald | 17475 | Germany |
| BDH-Klinik Greifswald gGmbH | Greifswald | 17491 | Germany |
| Kliniken Schmieder Heidelberg | Heidelberg | 69117 | Germany |
| Hospital zum Heiligen Geist Kempen | Kempen | 47906 | Germany |
| Tagesklinik MPI Leipzig | Leipzig | 04103 | Germany |
| Logo Zentrum Lindlar | Lindlar | 51789 | Germany |
| TheraVent aktiv Marbach | Marbach | 71672 | Germany |
| St. Mauritius Therapieklinik | Meerbusch | 40670 | Germany |
| EUFH Rostock | Rostock | 18057 | Germany |
| Aphasie-Zentrum Vechta gGmbH | Vechta | 49377 | Germany |
| Stahl B, Darkow R, von Podewils V, Meinzer M, Grittner U, Reinhold T, Grewe T, Breitenstein C, Floel A. Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia: A Randomized Controlled Trial Protocol. Front Neurol. 2019 Oct 22;10:1089. doi: 10.3389/fneur.2019.01089. eCollection 2019. |
| ID | Term |
|---|---|
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D013070 | Speech Therapy |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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