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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031164
Enrollment
14
Registered
2023-01-27
Start date
2023-01-30
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I69.3

Interventions

Group 1: Patients with left hemispheric stroke and aphasia will complete a 30 hours of a BCI-based language training (Breitenstein et al. (2017) four days per week (Teasell et al. 2018
Brady et al. 2016). The training consists of many short runs of 30 seconds to one minute each. Each run begins with a set of cues played through speakers or headphones. Only one word can complete the

Sponsors

Uniklinik Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Secondary

MeasureTime frame
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 .

Primary

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactMariacristina Musso

Klinik für Neurologie und Neurophysiologie

mariachristina.musso@uniklinik-freiburg.de+49 (0)761 27050010

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026