AphasiaNCT03930121

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

A study testing Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy) in people with Aphasia and Post-stroke, run by University Medicine Greifswald at 19 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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). Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Aphasia, Post-stroke
What is being tested?: Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 19 sitesGermany
Study dates: 6 Dec 2019to 4 Aug 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 12Show fewer

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.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

Germany19 sites

Aphasiestation RWTH Aachen
Aachen, 52074
Kliniken Schmieder Allensbach
Allensbach, 78476
Schön Klinik Bad Aibling Harthausen
Bad Aibling, 83209
Wicker Klinik Bad Homburg
Bad Homburg, 61348
Moritz Kliniken Bad Klosterlausnitz
Bad Klosterlausnitz, 07639
Median Klinik Bad Sülze
Bad Sülze, 18334
ZAR Berlin
Berlin, 10115
Kliniken Schmieder Gailingen
Gailingen, 78262
Klinikum Christophsbad Göppingen
Göppingen, 73035
University Medicine Greifswald, Department of Neurology
Greifswald, 17475
BDH-Klinik Greifswald gGmbH
Greifswald, 17491
Kliniken Schmieder Heidelberg
Heidelberg, 69117
Hospital zum Heiligen Geist Kempen
Kempen, 47906
Tagesklinik MPI Leipzig
Leipzig, 04103
Logo Zentrum Lindlar
Lindlar, 51789
TheraVent aktiv Marbach
Marbach, 71672
St. Mauritius Therapieklinik
Meerbusch, 40670
EUFH Rostock
Rostock, 18057
Aphasie-Zentrum Vechta gGmbH
Vechta, 49377

Other trials in Germany

About this study

Read the 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.

Conditions: Aphasia, Post-stroke
Being tested: Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)
Keywords: Rehabilitation, Intensive speech-language therapy, Transcranial direct current stimulation
Medical subject headings: Aphasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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)

Study groups in NCT03930121
Study group	Role	What they receive
Experimental group	Experimental	Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy) Receives: Other: 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 Receives: Other: Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups

Secondary outcomes (11)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 20194 Aug 2026

First posted29 Apr 2019
Study start6 Dec 2019
Primary completion4 Feb 2026 (estimated)
Study completion4 Aug 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AphasiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two daily sessions of intensive speech-language therapy combined with transcranial direct current stimulation of the left primary motor cortex (M1)
Masking: Single blind
Who is masked: Investigator
Enrolment: 130 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03930121
Sponsor's protocol ID: DC-Train-Aphasia
Status last verified: May 2025
First submitted: 16 Apr 2019
Last updated: 16 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 38175228
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.
PubMed 31695667

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke

All Aphasia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia
ClinicalTrials.gov ID: NCT03930121
Acronym / sponsor ID: DC-Train-Aphasia
Conditions: Aphasia, Post-stroke
Keywords: Rehabilitation, Intensive speech-language therapy, Transcranial direct current stimulation
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 130 participants (estimated)
Lead sponsor: University Medicine GreifswaldUniversity, hospital or other
Study start: 6 Dec 2019 (actual)
Primary completion: 4 Feb 2026 (estimated)
Study completion: 4 Aug 2026 (estimated)
First posted: 29 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: Two daily sessions of intensive speech-language therapy combined with transcranial direct current stimulation of the left primary motor cortex (M1)

Arm	Type	Receives
Experimental group	Experimental	Other: Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)
Control group	Sham comparator	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

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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);

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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)	Other	Control group, Experimental group

Primary outcome

Change in communication ability, as assessed by the Amsterdam Nijmegen Everyday Language Test
Time frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
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.

11 secondary outcomes

Change in naming ability, as assessed based on personally relevant trained and untrained items, consistent with previous work (see description)
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
Time frame: Before the 3-week treatment period; 6-month follow-up
Change in (non-)verbal communication, as assessed by the Communicative Effectiveness Index
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
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
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
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
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
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
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
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
Time frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Derived from this study: PubMed 38175228Unger 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.
Derived from this study: PubMed 31695667Stahl 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.
Individual participant dataSharing planned: No

Related trials for Aphasia

Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Agnes Floeel, Prof. principal investigator

University Medicine Greifswald

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in communication ability, as assessed by the Amsterdam Nijmegen Everyday Language Test (time frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03930121, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.