4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia

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

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).

Condition or disease Intervention/treatment Phase
Aphasia Post-stroke Other: Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy) Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia
Actual Study Start Date : December 6, 2019
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : March 31, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Experimental group
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)
Two daily sessions of intensive SLT combined with tDCS of the left primary motor cortex (M1)
Sham Comparator: Control group
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)
Two daily sessions of intensive SLT combined with tDCS of the left primary motor cortex (M1)
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Change in (non-)verbal communication, as assessed by the Scenario Test [ Time Frame: Before the 3-week treatment period; 6-month follow-up ]
    Scenario Test; cf. Nobis-Bosch R, Abel S, Krzok F, et al. Szenario Test-Testung verbaler und nonverbaler Aspekte aphasischer Kommunikation. ProLog, in preparation.

  3. 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 ]
    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.

  4. 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 ]
    Subscales Go/NoGo and Alertness from Test of Attentional Performance; cf. Zimmermann P and Fimm B. Testbatterie zur Aufmerksamkeitsprüfung (TAP). Herzogenrath: PSYTEST Verlag, 2002.

  5. 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 ]
    Figure Recognition Task from Benton Visual Retention Test; cf. Benton Sivan A and Spreen O. Benton Test. Bern: Huber, 2009.

  6. 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 ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    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.

  9. 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 ]
    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.

  10. 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 ]
    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.

  11. 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 ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 70% 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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Agnes Floeel, Prof. +49 3834 86 6815 agnes.floeel@uni-greifswald.de
Contact: Viola von Podewils, PhD +49 3834 866759 viola.podewils@uni-greifswald.de

Locations
Show Show 18 study locations
Sponsors and Collaborators
University Medicine Greifswald
Investigators
Layout table for investigator information
Principal Investigator: Agnes Floeel, Prof. University Medicine Greifswald
Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date August 26, 2020
Actual Study Start Date  ICMJE December 6, 2019
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • 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 ]
    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 [ Time Frame: Before the 3-week treatment period; 6-month follow-up ]
    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 [ Time Frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups ]
    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 [ Time Frame: Before the 3-week treatment period; 6-month follow up ]
    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 [ Time Frame: Before the 3-week treatment period; 6-month follow up ]
    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 [ Time Frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups ]
    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 [ Time Frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups ]
    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 [ Time Frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups ]
    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 [ Time Frame: Before the 3-week treatment period; 6- and 12-month follow ups ]
    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 [ Time Frame: Before the 3-week treatment period; 6- and 12-month follow ups ]
    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 [ Time Frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • 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 ]
    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 [ Time Frame: Before the 3-week treatment period; 6-month follow-up ]
    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 [ Time Frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups ]
    Communicative Effectiveness Index; cf. Lomas J, Pickard L, Bester S, et al. The Communicative Eeffectiveness 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 [ Time Frame: Before the 3-week treatment period; 6-month follow up ]
    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 [ Time Frame: Before the 3-week treatment period; 6-month follow up ]
    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 [ Time Frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups ]
    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 [ Time Frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups ]
    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 [ Time Frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups ]
    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 [ Time Frame: Before the 3-week treatment period; 6- and 12-month follow ups ]
    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 [ Time Frame: Before the 3-week treatment period; 6- and 12-month follow ups ]
    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 [ Time Frame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia
Official Title  ICMJE Transcranial Direct Current Stimulation to Enhance Training Effectiveness in Chronic Post-Stroke Aphasia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Aphasia
  • Post-stroke
Intervention  ICMJE Other: 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)
Study Arms  ICMJE
  • Experimental: Experimental group
    Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)
    Intervention: Other: Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)
  • Sham Comparator: Control group
    Placebo stimulation (using sham-tDCS) combined with SLT
    Intervention: Other: Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)
Publications * Stahl B, Darkow R, von Podewils V, Meinzer M, Grittner U, Reinhold T, Grewe T, Breitenstein C, Flöel 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019) 		130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 70% 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Agnes Floeel, Prof. +49 3834 86 6815 agnes.floeel@uni-greifswald.de
Contact: Viola von Podewils, PhD +49 3834 866759 viola.podewils@uni-greifswald.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930121
Other Study ID Numbers  ICMJE DC-Train-Aphasia
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Medicine Greifswald
Study Sponsor  ICMJE University Medicine Greifswald
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Agnes Floeel, Prof. University Medicine Greifswald
PRS Account University Medicine Greifswald
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯