Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Study of Non-invasive Repetitive Paraorbital Alternating Current Stimulation of the Brain: Therapy for Aphasy

Conditions
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Aphasia

Intervention / Treatment
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* Device: rtACS stimulation (Verum condition)
* Device: placebo condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum stimulation<br>repetitive transorbital alternating current stimulation (rtACS) | Device: rtACS stimulation (Verum condition)<br>* 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<br>|
| Sham Comparator: Placebo stimulation<br>Sham stimulation (placebo condition) no intervention | Device: placebo condition<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of speaking | 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 | between baseline and 60 days after stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful stabilization of language |  | 60 days after stimulation | 
| speaking functions 1 - communicative skills | 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) | baseline to 60 days after stimulation | 
| speaking functions 2 - spontaneous speech faculty | 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) | baseline to 60 days after stimulation | 
| speaking functions 3 - naming | 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) | baseline to 60 days after stimulation | 
| speaking functions 4 - repeating | 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) | baseline to 60 days after stimulation | 
| speaking functions 5 - understanding | 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) | baseline to 60 days after stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, aphasia, language