Clinical trial NCT03930121: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aphasia
Post-stroke
Keywords: Rehabilitation
Intensive speech-language therapy
Transcranial direct current stimulation
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two daily sessions of intensive speech-language therapy combined with transcranial direct current stimulation of the left primary motor cortex (M1)
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in communication ability, as assessed by the Amsterdam Nijmegen Everyday Language Test
timeFrame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
Secondary outcomes:
measure: Change in naming ability, as assessed based on personally relevant trained and untrained items, consistent with previous work (see description)
timeFrame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
measure: Change in (non-)verbal communication, as assessed by the Scenario Test
timeFrame: Before the 3-week treatment period; 6-month follow-up
measure: Change in (non-)verbal communication, as assessed by the Communicative Effectiveness Index
timeFrame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
measure: Change in attention and executive function, as assessed by the subscales Go/NoGo and Alertness from Test of Attentional Performance
timeFrame: Before the 3-week treatment period; 6-month follow up
measure: Change in non-verbal episodic memory, as assessed by the Figure Recognition Task from Benton Visual Retention Test
timeFrame: Before the 3-week treatment period; 6-month follow up
measure: Change in mood, as assessed by the German version of the 10-item Stroke Aphasic Depression Questionnaire
timeFrame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
measure: Change in health-related quality of life, as assessed by the Stroke and Aphasia Quality of Life Scale
timeFrame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
measure: Change in health-related quality of life, as assessed by the EuroQol Health-Related Quality of Life Questionnaire
timeFrame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
measure: Change in direct and indirect costs during the 12-month study period, as assessed by the self-developed Patient Resource Consumption Questionnaire
timeFrame: Before the 3-week treatment period; 6- and 12-month follow ups
measure: Change in direct and indirect costs during the 12-month study period, as assessed by the Quality-Adjusted Life Years
timeFrame: Before the 3-week treatment period; 6- and 12-month follow ups
measure: Change in unpaid support provided by family members or friends, as assessed by the Burden of informal caregivers
timeFrame: Before the 3-week treatment period; immediately after the 3-week treatment period; 6- and 12-month follow ups
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Aphasiestation RWTH Aachen
city: Allensbach
country: Germany
facility: Kliniken Schmieder Allensbach
city: Bad Aibling
country: Germany
facility: Schön Klinik Bad Aibling Harthausen
city: Bad Homburg
country: Germany
facility: Wicker Klinik Bad Homburg
city: Bad Klosterlausnitz
country: Germany
facility: Moritz Kliniken Bad Klosterlausnitz
city: Bad Sülze
country: Germany
facility: Median Klinik Bad Sülze
city: Berlin
country: Germany
facility: ZAR Berlin
city: Gailingen
country: Germany
facility: Kliniken Schmieder Gailingen
city: Greifswald
country: Germany
facility: University Medicine Greifswald, Department of Neurology
city: Greifswald
country: Germany
facility: BDH-Klinik Greifswald gGmbH
city: Göppingen
country: Germany
facility: Klinikum Christophsbad Göppingen
city: Heidelberg
country: Germany
facility: Kliniken Schmieder Heidelberg
city: Kempen
country: Germany
facility: Hospital zum Heiligen Geist Kempen
city: Leipzig
country: Germany
facility: Tagesklinik MPI Leipzig
city: Lindlar
country: Germany
facility: Logo Zentrum Lindlar
city: Marbach
country: Germany
facility: TheraVent aktiv Marbach
city: Meerbusch
country: Germany
facility: St. Mauritius Therapieklinik
city: Rostock
country: Germany
facility: EUFH Rostock
city: Vechta
country: Germany
facility: Aphasie-Zentrum Vechta gGmbH
Study officials:
affiliation: University Medicine Greifswald
name: Agnes Floeel, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.