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

Not Applicable

• Conditions: I69.3; Sequelae of cerebral infarction

• Registration Number: DRKS00013572
• Lead Sponsor: niklinik Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-01-20
• Study Start: 2020-01-04
• Results First Posted: 2022-02-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints, measured immediately before and after the training comprise the pre-/post differences between: <br>1) Functional communication, assessed by communication activity log (CAL) and<br>by analysis of spontaneous speech. <br>2) Naming ability, assessed by Snodgrass & Vanderwart naming test.<br>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.<br>4) Amplitudes and latency of event-related potentials of the electroencephalogram, bandpower of oscillatory EEG sources<br>5) Functional and structural connectivity, assessed by fMRI, DTI and EEG.<br>