Investigation of Brain-Computer Interfaces Neurotechnology for Novel Rehabilitation Approaches for Stroke-Induced Cognitive Deficits

Investigation of Brain-Computer Interfaces Neurotechnology for Novel Rehabilitation Approaches for Stroke-Induced Cognitive Deficits - CLEAR

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013572

Enrollment

Registered

2020-01-04

Start date

2017-07-07

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 chronic aphasia receive approx. 30 hours of BCI-based training each, using an auditory paradigm.

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aphasia (confirmed using the Aachener Aphasia Test [AAT]). 2) Right-handedness. 3) Age between 18-65 years. 4) First-ever, single left-hemispheric ischemic stroke. 5) Time since stroke at least 6 months. 6) Native German speaking. 7) Sufficient cognitive and language functions to comply with study task.

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) observed in MRI 4. Severe cerebral microangiopathy 5. Severe cerebral artery stenosis 6. Implanted medical devices or intracranial ferromagnetic objects 7. Skull lesion 8. Moderate to severe cognitive impairment 9. Neurological or psychiatric disorders interfering with participation and/or altering the interpretation of behavioral/imaging data (e.g. endogene depression, Morbus Parkinson) 10. Patient is early bilingual or professional musician 11. Hearing loss and/ or visual loss 12. Severe impairment of language understanding

Design outcomes

Primary

Measure	Time frame
Our primary outcome for the training success is based on the Aachener Aphasie Test (AAT), the most widely used standardized aphasia test in Germany. The test captures individual changes of language functions. Primary endpoint is the pre-post difference of the T-transformed result score of the AAT. A speech therapist performs this test immediately before the start of the 30 hours of training, after 15 hours of training, after the end of the training, and three months after the end of the training.	—

Measure

Time frame

Our primary outcome for the training success is based on the Aachener Aphasie Test (AAT), the most widely used standardized aphasia test in Germany. The test captures individual changes of language functions. Primary endpoint is the pre-post difference of the T-transformed result score of the AAT. A speech therapist performs this test immediately before the start of the 30 hours of training, after 15 hours of training, after the end of the training, and three months after the end of the training.

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Secondary

Measure	Time frame
Secondary endpoints, measured immediately before and after the training comprise the pre-/post differences between: 1) Functional communication, assessed by communication activity log (CAL) and by analysis of spontaneous speech. 2) Naming ability, assessed by Snodgrass & Vanderwart naming test. 3) Cognitive abilities, assessed by a battery comprising the digit span test,b lock-tapping test, Regensburger Wortflüssigkeits-Test, test for attention performance (TAP) and the trail making test. 4) Amplitudes and latency of event-related potentials of the electroencephalogram, bandpower of oscillatory EEG sources 5) Functional and structural connectivity, assessed by fMRI, DTI and EEG.	—

Measure

Time frame

Secondary endpoints, measured immediately before and after the training comprise the pre-/post differences between: 1) Functional communication, assessed by communication activity log (CAL) and by analysis of spontaneous speech. 2) Naming ability, assessed by Snodgrass & Vanderwart naming test. 3) Cognitive abilities, assessed by a battery comprising the digit span test,b lock-tapping test, Regensburger Wortflüssigkeits-Test, test for attention performance (TAP) and the trail making test. 4) Amplitudes and latency of event-related potentials of the electroencephalogram, bandpower of oscillatory EEG sources 5) Functional and structural connectivity, assessed by fMRI, DTI and EEG.

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Countries

Germany

Contacts

Public ContactMariachristina Musso

Universitätsklinikum FreiburgNeurozentrum

mariachristina.musso@uniklinik-freiburg.de076127052980

Outcome results

None listed

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