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

N/AActive Not RecruitingNCT03930121

University Medicine Greifswald130 enrolled

Overview

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).

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

130

Conditions

Aphasia Post-stroke

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (19)

Aphasiestation RWTH Aachen

Aachen, Germany

Kliniken Schmieder Allensbach

Allensbach, Germany

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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

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

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.

Time frame: 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

Data from ClinicalTrials.gov

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