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

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).

Study Overview

• Status: Recruiting
• Conditions: Aphasia; Post-stroke
• Intervention / Treatment: Other: Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Agnes Floeel, Prof.; Phone Number: +49 3834 86 6815; Email: agnes.floeel@uni-greifswald.de
• Study Contact Backup: Name: Nina Unger; Phone Number: +49 3834 86 6749; Email: nina.unger@uni-greifswald.de

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • Aphasiestation RWTH Aachen
    • Contact: Beate Schumann; Phone Number: 0241/8088556; Email: bschumann@ukaachen.de
  • Allensbach, Germany, 78476
    • Recruiting
    • Kliniken Schmieder Allensbach
    • Contact: Berthold Gröne; Phone Number: 07533/8081456; Email: b.groene@kliniken-schmieder.de
  • Bad Aibling, Germany, 83209
    • Recruiting
    • Schön Klinik Bad Aibling Harthausen
    • Contact: Gudrun Klingenberg, Dr.; Phone Number: 08061/9031581; Email: gklingenberg@schoen-klinik.de
  • Bad Homburg, Germany, 61348
    • Recruiting
    • Wicker Klinik Bad Homburg
    • Contact: Carla Berghoff, Dr.; Phone Number: 06172/103160; Email: berghoff@wickerklinik.de
  • Bad Klosterlausnitz, Germany, 07639
    • Recruiting
    • Moritz Kliniken Bad Klosterlausnitz
    • Contact: Anke Oertel; Phone Number: 036601/ 49521; Email: anke.oertel@moritz-klinik.de
  • Bad Sülze, Germany, 18334
    • Recruiting
    • Median Klinik Bad Sülze
    • Contact: Daniela Fürst; Phone Number: 038229/72530; Email: daniela.fuerst@median-kliniken.de
  • Berlin, Germany, 10115
    • Recruiting
    • ZAR Berlin
    • Contact: Anke Nicklas; Phone Number: 030/285184555; Email: nicklas@zar-berlin.de
  • Gailingen, Germany, 78262
    • Recruiting
    • Kliniken Schmieder Gailingen
    • Contact: Berthold Gröne; Phone Number: 07533/8081456; Email: b.groene@kliniken-schmieder.de
  • Greifswald, Germany, 17475
    • Recruiting
    • University medicine Greifswald, department of Neurology
    • Contact: Agnes Floeel, Prof; Phone Number: +49 (03834) 86 6815; Email: agnes.floeel@uni-greifswald.de
    • Contact: Nina Unger; Phone Number: +49 (03834) 86 6749; Email: nina.unger@uni-greifswald.de
  • Greifswald, Germany, 17491
    • Recruiting
    • BDH-Klinik Greifswald gGmbH
    • Contact: Thomas Platz, Prof. Dr.; Phone Number: 03834/871201; Email: Sekretariataed@bdh-klinikgreifswald.de
  • Göppingen, Germany, 73035
    • Recruiting
    • Klinikum Christophsbad Göppingen
    • Contact: Angelika Kartmann; Phone Number: 07161/6019650; Email: angelika.kartmann@christophsbad.de
  • Heidelberg, Germany, 69117
    • Recruiting
    • Kliniken Schmieder Heidelberg
    • Contact: Desirée Kämpfer; Phone Number: 06221/6540390; Email: d.kaempfer@kliniken-schmieder.de
  • Kempen, Germany, 47906
    • Recruiting
    • Hospital zum Heiligen Geist Kempen
    • Contact: Nathalie Stute; Phone Number: 02512/1421311; Email: nathalie.stute@artemed.de
  • Leipzig, Germany, 04103
    • Recruiting
    • Tagesklinik MPI Leipzig
    • Contact: Frank Regenbrecht; Phone Number: 0341/9724980; Email: frank.regenbrecht@medizin.uni-leipzig.de
  • Lindlar, Germany, 51789
    • Recruiting
    • Logo Zentrum Lindlar
    • Contact: Tina Keck; Phone Number: 02266/9060; Email: tina.keck@logozentrumlindlar.de
  • Marbach, Germany, 71672
    • Recruiting
    • TheraVent aktiv Marbach
    • Contact: Katrin Baumann; Phone Number: 07144/160960; Email: katrin.baumann@theravent-aktiv.de
  • Meerbusch, Germany, 40670
    • Recruiting
    • St. Mauritius Therapieklinik
    • Contact: Stefanie Brühl, PD Dr.; Phone Number: 02159/6795216; Email: stefanie.bruehl@stmtk.de
  • Vechta, Germany, 49377
    • Recruiting
    • Aphasie-Zentrum Vechta gGmbH
    • Contact: Stephan Benhamza; Phone Number: 04447/970134
    • Contact: Kathrin Billo; Phone Number: 04447/970134; Email: kathrin.billo@aphasie-zentrum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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); Two daily sessions of intensive SLT combined with tDCS of the left primary motor cortex (M1)
Sham Comparator: Control group; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Principal Investigator: Agnes Floeel, Prof., University Medicine Greifswald

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Estimated): February 4, 2024
• Study Completion (Estimated): August 4, 2024

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Transcranial direct current stimulation; Intensive speech-language therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stroke; Aphasia
• Other Study ID Numbers: DC-Train-Aphasia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No