CLEAR: Aphasia rehabilitation with EEG-based feedback - A randomised controlled trial.

Not Applicable

Recruiting

Conditions: I69.3
Sequelae of cerebral infarction

Registration Number: DRKS00031164

Lead Sponsor: niklinik Freiburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 14

Inclusion Criteria

aphasia (confirmed using the Aachen Aphasia Test [AAT])
aged between 18-80
the presence of aphasia in AAT
right-handed
first-ever left-hemispheric ischemic stroke;
time onset of stroke at least 6 months ago
German as mother language
sufficient (cognitive and language) functions to comply with study task and requirements

Exclusion Criteria

1.hemorrhagic stroke
2.aphasia due to right hemispheric stroke
3.more than one stroke or other structural brain lesion (tumor, trauma) in MRI
4.high cerebral microangiopathy
5.high cerebral artery stenosis
6.implanted medical devices or intracranial ferromagnetic objects
7.skull lesions
8.mild/severe cognitive impairment and other medical
9.neurological or psychiatric disorders interfering with participation and/or alter the interpretation of
behavioral/imaging data (e.g. endogene depression, Morbus Parkinson)
10.patient is early bilingual or professional musician
11.hearing and visual loss

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the language perfromance on the Aachen Aphasia Test (AAT), the most widely used standardised aphasia test in Germany. This test is administered by a speech therapist before, after and 3 months after the training. Individual changes in language functions are evaluated on the basis of the AAT manual. The T-transformed scores of the AAT subtest results (a standardisation in which the scores are transferred to a scale with a mean of 50 and a standard deviation of 10) will be compared by repeated-measures analyses of variance between the groups, across the different measurement time points (pre, post and follow-up). If necessary, the Greenhouse Geisser (G-G) correction is applied.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are: the quantification and qualification of a) functional communication through the Communication Activity Log (CAL) and spontaneous speech, b) naming abilities through the Snodgrass & Vanderwart Naming Test c) cognitive abilities based on a test battery consisting of the Digit Span Test, the Block Tapping Test, the TAP and the Trail Making Test. In addition, the following will be measured in the pre- and post-training : a) maximum amplitudes, latency and onset of different event-related potentials (especially P300 and N200) b) functional connectivity and c) structural connectivity .