Aphasia
Conditions
Keywords
stroke, aphasia, language
Brief summary
The investigators assess if repetitive, transcranial alternating current stimulation (rtACS) can improve the speaking quality of the aphasic patient as well as other communication skills as naming, repeating and understanding spoken words, reading and writing. Further, it will be assessed if memory and attentiveness deficiencies after 10 days of therapy with brain stimulation are stabilized and remain stable after a training-free period of 60 days.
Interventions
DEVICErtACS stimulation (Verum condition)
Repetitive, transorbital alternating current stimulation (rtACS) is applied with multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 microA. Current intensity is individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation
DEVICEplacebo condition
A clicking sound is presented and the same electrode montage set-up is used during rtASC- and Placebo-stimulation, except that placebo patients received no current (stimulator turned off).
Sponsors
EBS Technologies GmbH
University of Magdeburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* stroke * lesion age at least 6 months * aphasia with at least moderate severity according to Aachener Aphasia Test (AAT) * age between 40 and 75 * German-speaking (at a native speaking level)
Exclusion criteria
* cognitive or speech-language therapy during the 2-weeks stimulation course * intensive language training when exceeding 1 hour, 2 times a week during the 2-weeks stimulation course and the follow-up period (60 days after stimulation was completed) * additional neurological diseases, e.g. surgical brain tumor removal, untreated tumor disease, acute traumatic brain injury, and/or craniotomy * (severe) dysarthria * untreated hypertension exceeding 160/100 mmHg (patients with treated hypertension and blood pressure below 160/100 mmHg can be included) * increased risk of vascular thrombosis * epilepsy, photo sensitivity, acute focal findings (patients without focal findings or epileptiform discharges can be included when they had only a single seizure more than 10 years ago) * dementias and neurodegenerative diseases * significant psychiatric disturbances, e.g. schizophrenia * major attention and/or memory deficits * major hearing loss * patients with uncorrected visual deficits * severe global aphasia * modality-specific disorders (pure speech apraxia, pure alexia, pure agraphia) * electric or electronic implants (e.g. heart pacemakers) * metal artefacts located at the head * medication with impact on the central nervous system (e.g. antidepressant or sedative drugs) * participation in another trial * pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement of speaking | between baseline and 60 days after stimulation | assessed by the following tests: * Expressive speaking: ANELT (Amsterdam Nijmegen Everyday Language Test), Aachener Aphasie Test * receptive speaking: ANELT (Amsterdam Nijmegen Everyday Language Test), Aachener Aphasie Test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| speaking functions 1 - communicative skills | baseline to 60 days after stimulation | * reading and writing: Aachener Aphasy Test * attentiveness: TAP test battery * working Memory: Wechsler Memory scale-Revised (WMS-R) * emitional state: Vision Analogous Mood Scale (VAMS) |
| speaking functions 2 - spontaneous speech faculty | baseline to 60 days after stimulation | * reading and writing: Aachener Aphasy Test * attentiveness: TAP test battery * working Memory: Wechsler Memory scale-Revised (WMS-R) * emitional state: Vision Analogous Mood Scale (VAMS) |
| successful stabilization of language | 60 days after stimulation | — |
| speaking functions 4 - repeating | baseline to 60 days after stimulation | * reading and writing: Aachener Aphasy Test * attentiveness: TAP test battery * working Memory: Wechsler Memory scale-Revised (WMS-R) * emitional state: Vision Analogous Mood Scale (VAMS) |
| speaking functions 5 - understanding | baseline to 60 days after stimulation | * reading and writing: Aachener Aphasy Test * attentiveness: TAP test battery * working Memory: Wechsler Memory scale-Revised (WMS-R) * emitional state: Vision Analogous Mood Scale (VAMS) |
| speaking functions 3 - naming | baseline to 60 days after stimulation | * reading and writing: Aachener Aphasy Test * attentiveness: TAP test battery * working Memory: Wechsler Memory scale-Revised (WMS-R) * emitional state: Vision Analogous Mood Scale (VAMS) |
Countries
Germany
Outcome results
None listed