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ID
Source
Brief title
Health condition
We will study participants with aphasia, an acquired language disorder caused by stroke.
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De participanten van het onderzoek hebben afasie, een niet-aangeboren taalstoornis die door een beroerte (CVA) is ontstaan.
Sponsors and support
Intervention
Outcome measures
Primary outcome
language 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
Background summary
In 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.
Study objective
We 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.
Study design
5 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
Intervention
The 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.
Westersingel 300
K. Spielmann
Rotterdam
The Netherlands
010 2412412
KSpielmann@rijndam.nl
Westersingel 300
K. Spielmann
Rotterdam
The Netherlands
010 2412412
KSpielmann@rijndam.nl
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL4211 |
| NTR-old | NTR4364 |
| Other | METC : MEC-2013-147 |