Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

Phase 3

Terminated

• Conditions: Aphasia
• Interventions: Device: rtACS stimulation (Verum condition); Device: placebo condition

• Registration Number: NCT01277575
• Lead Sponsor: University of Magdeburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Status Verified: 2011-01
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum stimulation	rtACS stimulation (Verum condition)	repetitive transorbital alternating current stimulation (rtACS)
Placebo stimulation	placebo condition	Sham stimulation (placebo condition) no intervention

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
successful stabilization of language	60 days after stimulation
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)
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)
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)

Trial Locations

Locations (3)

Neurologische Klinik, Medizinische Fakultät der RWTH Aachen, Pauwelsstr. 30; 🇩🇪 Aachen, Germany

Neurologische Klinik, Brandenburg Klinik Bernau, Brandenburgallee 1; 🇩🇪 Bernau Waldsiedlung, Germany

Institut für Medizinische Psychologie, Leipziger Str. 44; 🇩🇪 Magdeburg, Germany