Back to results

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

Primary Purpose

Aphasia, Post-stroke

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Rehabilitation, Intensive speech-language therapy, Transcranial direct current stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Aphasiestation RWTH AachenRecruiting
Kliniken Schmieder AllensbachRecruiting
Schön Klinik Bad Aibling HarthausenRecruiting
Wicker Klinik Bad HomburgRecruiting
Moritz Kliniken Bad KlosterlausnitzRecruiting
Median Klinik Bad SülzeRecruiting
ZAR BerlinRecruiting
Kliniken Schmieder GailingenRecruiting
University medicine Greifswald, department of NeurologyRecruiting
BDH-Klinik Greifswald gGmbHRecruiting
Klinikum Christophsbad GöppingenRecruiting
Kliniken Schmieder HeidelbergRecruiting
Hospital zum Heiligen Geist KempenRecruiting
Tagesklinik MPI LeipzigRecruiting
Logo Zentrum LindlarRecruiting
TheraVent aktiv MarbachRecruiting
St. Mauritius TherapieklinikRecruiting
Aphasie-Zentrum Vechta gGmbHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03930121

First Posted

April 16, 2019

Last Updated

June 5, 2023

Sponsor

University Medicine Greifswald

1. Study Identification

Unique Protocol Identification Number

NCT03930121

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 6, 2019 (Actual)

Primary Completion Date

February 4, 2024 (Anticipated)

Study Completion Date

August 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Medicine Greifswald

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aphasia, Post-stroke

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Investigator

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Sham Comparator

Arm Description

Placebo stimulation (using sham-tDCS) combined with SLT

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in communication ability, as assessed by the Amsterdam Nijmegen Everyday Language Test

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Change in (non-)verbal communication, as assessed by the Scenario Test

Description

Scenario Test; cf. Nobis-Bosch R, Abel S, Krzok F, et al. Szenario Test-Testung verbaler und nonverbaler Aspekte aphasischer Kommunikation. ProLog, in preparation.

Time Frame

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

Title

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

Description

Time Frame

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

Title

Change in attention and executive function, as assessed by the subscales Go/NoGo and Alertness from Test of Attentional Performance

Description

Subscales Go/NoGo and Alertness from Test of Attentional Performance; cf. Zimmermann P and Fimm B. Testbatterie zur Aufmerksamkeitsprüfung (TAP). Herzogenrath: PSYTEST Verlag, 2002.

Time Frame

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

Title

Change in non-verbal episodic memory, as assessed by the Figure Recognition Task from Benton Visual Retention Test

Description

Figure Recognition Task from Benton Visual Retention Test; cf. Benton Sivan A and Spreen O. Benton Test. Bern: Huber, 2009.

Time Frame

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

Title

Change in mood, as assessed by the German version of the 10-item Stroke Aphasic Depression Questionnaire

Description

Time Frame

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

Title

Change in health-related quality of life, as assessed by the Stroke and Aphasia Quality of Life Scale

Description

Time Frame

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

Title

Change in health-related quality of life, as assessed by the EuroQol Health-Related Quality of Life Questionnaire

Description

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.

Time Frame

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

Title

Change in direct and indirect costs during the 12-month study period, as assessed by the self-developed Patient Resource Consumption Questionnaire

Description

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.

Time Frame

Before the 3-week treatment period; 6- and 12-month follow ups

Title

Change in direct and indirect costs during the 12-month study period, as assessed by the Quality-Adjusted Life Years

Description

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.

Time Frame

Before the 3-week treatment period; 6- and 12-month follow ups

Title

Change in unpaid support provided by family members or friends, as assessed by the Burden of informal caregivers

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Agnes Floeel, Prof.

Phone

+49 3834 86 6815

agnes.floeel@uni-greifswald.de

First Name & Middle Initial & Last Name or Official Title & Degree

Nina Unger

Phone

+49 3834 86 6749

nina.unger@uni-greifswald.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Agnes Floeel, Prof.

Organizational Affiliation

University Medicine Greifswald

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aphasiestation RWTH Aachen

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beate Schumann

Phone

0241/8088556

bschumann@ukaachen.de

Facility Name

Kliniken Schmieder Allensbach

City

Allensbach

ZIP/Postal Code

78476

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Berthold Gröne

Phone

07533/8081456

b.groene@kliniken-schmieder.de

Facility Name

Schön Klinik Bad Aibling Harthausen

City

Bad Aibling

ZIP/Postal Code

83209

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gudrun Klingenberg, Dr.

Phone

08061/9031581

gklingenberg@schoen-klinik.de

Facility Name

Wicker Klinik Bad Homburg

City

Bad Homburg

ZIP/Postal Code

61348

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carla Berghoff, Dr.

Phone

06172/103160

berghoff@wickerklinik.de

Facility Name

Moritz Kliniken Bad Klosterlausnitz

City

Bad Klosterlausnitz

ZIP/Postal Code

07639

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anke Oertel

Phone

036601/ 49521

anke.oertel@moritz-klinik.de

Facility Name

Median Klinik Bad Sülze

City

Bad Sülze

ZIP/Postal Code

18334

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniela Fürst

Phone

038229/72530

daniela.fuerst@median-kliniken.de

Facility Name

ZAR Berlin

City

Berlin

ZIP/Postal Code

10115

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anke Nicklas

Phone

030/285184555

nicklas@zar-berlin.de

Facility Name

Kliniken Schmieder Gailingen

City

Gailingen

ZIP/Postal Code

78262

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Berthold Gröne

Phone

07533/8081456

b.groene@kliniken-schmieder.de

Facility Name

University medicine Greifswald, department of Neurology

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agnes Floeel, Prof

Phone

+49 (03834) 86 6815

agnes.floeel@uni-greifswald.de

First Name & Middle Initial & Last Name & Degree

Nina Unger

Phone

+49 (03834) 86 6749

nina.unger@uni-greifswald.de

Facility Name

BDH-Klinik Greifswald gGmbH

City

Greifswald

ZIP/Postal Code

17491

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas Platz, Prof. Dr.

Phone

03834/871201

Sekretariataed@bdh-klinikgreifswald.de

Facility Name

Klinikum Christophsbad Göppingen

City

Göppingen

ZIP/Postal Code

73035

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Angelika Kartmann

Phone

07161/6019650

angelika.kartmann@christophsbad.de

Facility Name

Kliniken Schmieder Heidelberg

City

Heidelberg

ZIP/Postal Code

69117

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Desirée Kämpfer

Phone

06221/6540390

d.kaempfer@kliniken-schmieder.de

Facility Name

Hospital zum Heiligen Geist Kempen

City

Kempen

ZIP/Postal Code

47906

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nathalie Stute

Phone

02512/1421311

nathalie.stute@artemed.de

Facility Name

Tagesklinik MPI Leipzig

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frank Regenbrecht

Phone

0341/9724980

frank.regenbrecht@medizin.uni-leipzig.de

Facility Name

Logo Zentrum Lindlar

City

Lindlar

ZIP/Postal Code

51789

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tina Keck

Phone

02266/9060

tina.keck@logozentrumlindlar.de

Facility Name

TheraVent aktiv Marbach

City

Marbach

ZIP/Postal Code

71672

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katrin Baumann

Phone

07144/160960

katrin.baumann@theravent-aktiv.de

Facility Name

St. Mauritius Therapieklinik

City

Meerbusch

ZIP/Postal Code

40670

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefanie Brühl, PD Dr.

Phone

02159/6795216

stefanie.bruehl@stmtk.de

Facility Name

Aphasie-Zentrum Vechta gGmbH

City

Vechta

ZIP/Postal Code

49377

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephan Benhamza

Phone

04447/970134

First Name & Middle Initial & Last Name & Degree

Kathrin Billo

Phone

04447/970134

kathrin.billo@aphasie-zentrum.de

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31695667

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs