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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930121
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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)




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.



Information from the National Library of Medicine

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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 60% 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., epilepsy, brain tumor, and subdural hematoma);
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930121


Contacts
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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
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Principal Investigator: Agnes Floeel, Prof. University Medicine Greifswald
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT03930121    
Other Study ID Numbers: DC-Train-Aphasia
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Medicine Greifswald:
Rehabilitation
Intensive speech-language therapy
Transcranial direct current stimulation
Additional relevant MeSH terms:
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Stroke
Aphasia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms