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

NCT ID: NCT03930121

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-06
• Study Completion Date: 2026-08-04

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)

Group Type: EXPERIMENTAL

Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)

Intervention Type: OTHER

Two daily sessions of intensive SLT combined with tDCS of the left primary motor cortex (M1)

Control group

Placebo stimulation (using sham-tDCS) combined with SLT

Group Type: SHAM_COMPARATOR

Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)

Intervention Type: OTHER

Two daily sessions of intensive SLT combined with tDCS of the left primary motor cortex (M1)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Agnes Floeel, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Medicine Greifswald

Locations

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

University Medicine Greifswald, Department of Neurology

Greifswald, , Germany

BDH-Klinik Greifswald gGmbH

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

EUFH Rostock

Rostock, , Germany

Aphasie-Zentrum Vechta gGmbH

Vechta, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 38175228 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31695667 (View on PubMed)

Other Identifiers

DC-Train-Aphasia

Identifier Type: -

Identifier Source: org_study_id