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

Last updated: May 21, 2024
Sponsor: University Medicine Greifswald
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Communication Disorders

Treatment

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

Clinical Study ID

NCT03930121
DC-Train-Aphasia
  • Ages 18-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 acomputerized 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 oftDCS electrodes, as confirmed by magnetic resonance imaging or computer tomographyscans.

Exclusion

Exclusion Criteria:

  • contraindications for tDCS (e.g., cardiac pacemaker, history of seizures, implantedmetal 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 intakeof 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 inintensive SLT;

  • changes in centrally active drugs within 2 weeks prior to study inclusion.

Study Design

Total Participants: 130
Treatment Group(s): 1
Primary Treatment: Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)
Phase:
Study Start date:
December 06, 2019
Estimated Completion Date:
August 04, 2025

Study 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.

Connect with a study center

  • Aphasiestation RWTH Aachen

    Aachen, 52074
    Germany

    Active - Recruiting

  • Kliniken Schmieder Allensbach

    Allensbach, 78476
    Germany

    Active - Recruiting

  • Schön Klinik Bad Aibling Harthausen

    Bad Aibling, 83209
    Germany

    Active - Recruiting

  • Wicker Klinik Bad Homburg

    Bad Homburg, 61348
    Germany

    Active - Recruiting

  • Moritz Kliniken Bad Klosterlausnitz

    Bad Klosterlausnitz, 07639
    Germany

    Active - Recruiting

  • Median Klinik Bad Sülze

    Bad Sülze, 18334
    Germany

    Active - Recruiting

  • ZAR Berlin

    Berlin, 10115
    Germany

    Active - Recruiting

  • Kliniken Schmieder Gailingen

    Gailingen, 78262
    Germany

    Active - Recruiting

  • BDH-Klinik Greifswald gGmbH

    Greifswald, 17491
    Germany

    Active - Recruiting

  • University medicine Greifswald, department of Neurology

    Greifswald, 17475
    Germany

    Active - Recruiting

  • Klinikum Christophsbad Göppingen

    Göppingen, 73035
    Germany

    Active - Recruiting

  • Kliniken Schmieder Heidelberg

    Heidelberg, 69117
    Germany

    Active - Recruiting

  • Hospital zum Heiligen Geist Kempen

    Kempen, 47906
    Germany

    Active - Recruiting

  • Tagesklinik MPI Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Logo Zentrum Lindlar

    Lindlar, 51789
    Germany

    Active - Recruiting

  • TheraVent aktiv Marbach

    Marbach, 71672
    Germany

    Active - Recruiting

  • St. Mauritius Therapieklinik

    Meerbusch, 40670
    Germany

    Active - Recruiting

  • Aphasie-Zentrum Vechta gGmbH

    Vechta, 49377
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.