Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

University of Magdeburg

Status and phase

Terminated

Phase 3

Conditions

Aphasia

Treatments

Device: placebo condition

Device: rtACS stimulation (Verum condition)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01277575

EBS-PP-2010-08-25-001

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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