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tDCS and aphasia


- candidate number16526
- NTR NumberNTR4364
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-feb-2014
- Secondary IDsMEC-2013-147 METC
- Public TitletDCS and aphasia
- Scientific TitletDCS and aphasia
- ACRONYMTEA
- hypothesisWe expect that tDCS will enhance speed of language recovery, resulting in improved communication, quality of life and participation - associated with decreased rehabilitation consumption and cost reduction.
- Healt Condition(s) or Problem(s) studiedStroke, Aphasia
- Inclusion criteria-Aphasia after stroke -Time post onset < 3 months -Age 18-75 years -Right handed -Physical health sufficient to participate in intensive aphasia therapy
- Exclusion criteria-Subarachnoïd Haemorrhage (SAH) -Prior stroke resulting in aphasia -Brain surgery in the past -Epileptic activity in the past 12 months -Excessive use of alcohol or drugs -Insufficient level of Dutch premorbidly -Premorbid (suspected) dementia -Premorbid psychiatric disease affecting communication -Severe non-linguistic cognitive disturbances impeding language therapy -Pace maker -Global aphasia (spontaneous speech 0 AND shortened Token Test < 9) -Severe Wernicke’s aphasia (spontaneous speech 0-1 AND shortened Token Test <9) -Residual aphasia (spontaneous speech 4-5 AND shortened Token Test > 28 AND Boston Naming Test > 150)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2013
- planned closingdate1-nov-2017
- Target number of participants58
- InterventionsThe intervention is tDCS (Transcraniele Direct Current Stimulation). We will study whether tDCS has an additional effect in the rehabilitation of aphasia. To investigate this, two groups will be studied: 1 group receives real current stimulation and 1 group receives no current stimulation (sham-tDCS). The intervention (real tDCS or sham-tDCS)will be added to language therapy sessions. Two seperate intervention weeks will be planned, in each week the participants will get 5 1-hoursessions of real tDCS or sham-tDCS+language therapy.
- Primary outcomelanguage functioning i.e. word finding (Boston naming test)
- Secondary outcome- Communication. Test: ANTAT - Quality of life. Questionnaires: SAQOL, Euroqol-5D - Care consumption. Questionnaires: Werk en zorg vragenlijst (Health care consumption and labour productivity) - Laterality index. Measurement: fMRI Other outcomes: - demographic data (age, gender, handedness, educational level, socio-economic status) - aphasia type and severity - Size and location of the lesion (fMRI) - Participation: CIQ - overall functioning: Barthel Index - adverse effects: Wong-Baker FACES Pain Rating Scale
- Timepoints5 timepoints for language tests&questionnaires: - before intervention week 1 - after intervention week 1 - before intervention week 2 - after intervention week 2 - follow-up: 6 months For the fMRI, there are 2 timepoints: - before intervention week 1 - after intervention week 2
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES K. Spielmann
- CONTACT for SCIENTIFIC QUERIES K. Spielmann
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus University Medical Centre, M-RACE
- Publications
- Brief summaryIn summary, we will study whether tDCS has an additional effect in the rehabilitation of aphasia. To investigate this, two groups will be studied: 1 group receives real current stimulation and 1 group receives no current stimulation (sham-tDCS). The intervention (real tDCS or sham-tDCS)will be added to language therapy sessions. We hypothesise that real tDCS will lead to a significant improvement in language functioning, and that this group difference will also be there at 6 months follow-up.
- Main changes (audit trail)20-3-2014: trial overgezet naar website - LH
- RECORD21-feb-2014 - 8-apr-2014


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