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

Aphasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03930121
• Other study ID #: DC-Train-Aphasia
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2019
• Est. completion date: August 4, 2024

Study information

• Verified date: June 2023
• Source: University Medicine Greifswald
• Contact: Agnes Floeel, Prof.
• Phone: +49 3834 86 6815
• Email: agnes.floeel[@]uni-greifswald.de
• Is FDA regulated: No
• 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, 2024
• Est. primary completion date: February 4, 2024
• 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.

Related Conditions & MeSH terms

• Aphasia
• Post-stroke
• Stroke

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