An interventional study of Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy) in Aphasia and Post-stroke, sponsored by University Medicine Greifswald. Active, not recruiting at 19 sites in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by University Medicine Greifswald · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 130 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University Medicine Greifswald is the lead sponsor of 149 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)
Other: Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)
Placebo stimulation (using sham-tDCS) combined with SLT
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)
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.
Time frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
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.
Time frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
Plan to share: No
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University Medicine Greifswald