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

NCT03930121 | Active Not Recruiting

• 1 other identifier: DC-Train-Aphasia
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 19

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).

Conditions

Aphasia; Post-stroke

Keywords

Rehabilitation; Intensive speech-language therapy; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in naming ability, as assessed based on personally relevant trained and untrained items, consistent with previous work (see description)

  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

  Before the 3-week treatment period; 6-month follow-up

• Change in (non-)verbal communication, as assessed by the Communicative Effectiveness Index

  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

  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

  Before the 3-week treatment period; 6-month follow up

Study Arms (2)

Experimental group

EXPERIMENTAL

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)

Control group

SHAM COMPARATOR

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)

Interventions

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)

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (19)

Aphasiestation RWTH Aachen

Aachen, 52074, Germany

Location

Kliniken Schmieder Allensbach

Allensbach, 78476, Germany

Location

Schön Klinik Bad Aibling Harthausen

Bad Aibling, 83209, Germany

Location

Wicker Klinik Bad Homburg

Bad Homburg, 61348, Germany

Location

Moritz Kliniken Bad Klosterlausnitz

Bad Klosterlausnitz, 07639, Germany

Location

Median Klinik Bad Sülze

Bad Sülze, 18334, Germany

Location

ZAR Berlin

Berlin, 10115, Germany

Location

Kliniken Schmieder Gailingen

Gailingen, 78262, Germany

Location

Klinikum Christophsbad Göppingen

Göppingen, 73035, Germany

Location

University Medicine Greifswald, Department of Neurology

Greifswald, 17475, Germany

Location

BDH-Klinik Greifswald gGmbH

Greifswald, 17491, Germany

Location

Kliniken Schmieder Heidelberg

Heidelberg, 69117, Germany

Location

Hospital zum Heiligen Geist Kempen

Kempen, 47906, Germany

Location

Tagesklinik MPI Leipzig

Leipzig, 04103, Germany

Location

Logo Zentrum Lindlar

Lindlar, 51789, Germany

Location

TheraVent aktiv Marbach

Marbach, 71672, Germany

Location

St. Mauritius Therapieklinik

Meerbusch, 40670, Germany

Location

EUFH Rostock

Rostock, 18057, Germany

Location

Aphasie-Zentrum Vechta gGmbH

Vechta, 49377, Germany

Location

Related Publications (2)

• 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.

  PMID: 38175228 DERIVED

• 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.

  PMID: 31695667 DERIVED

MeSH Terms

Conditions

Aphasia

Interventions

Transcranial Direct Current Stimulation; Speech Therapy

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Agnes Floeel, Prof.

  University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two daily sessions of intensive speech-language therapy combined with transcranial direct current stimulation of the left primary motor cortex (M1)

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 29, 2019
• Study Start: December 6, 2019
• Primary Completion: February 4, 2026
• Study Completion (Estimated): August 4, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (19)