Clinical trial NCT01277575: Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia
Official title: Multicenter Study of Non-invasive Repetitive Paraorbital Alternating Current Stimulation of the Brain: Therapy for Aphasy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Aphasia
Keywords: stroke
aphasia
language
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
Collaborators: name: EBS Technologies GmbH
First posted: 2011-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: improvement of speaking
timeFrame: between baseline and 60 days after stimulation
Secondary outcomes:
measure: successful stabilization of language
timeFrame: 60 days after stimulation
measure: speaking functions 1 - communicative skills
timeFrame: baseline to 60 days after stimulation
measure: speaking functions 2 - spontaneous speech faculty
timeFrame: baseline to 60 days after stimulation
measure: speaking functions 3 - naming
timeFrame: baseline to 60 days after stimulation
measure: speaking functions 4 - repeating
timeFrame: baseline to 60 days after stimulation
measure: speaking functions 5 - understanding
timeFrame: baseline to 60 days after stimulation
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Neurologische Klinik, Medizinische Fakultät der RWTH Aachen, Pauwelsstr. 30
city: Bernau Waldsiedlung
country: Germany
facility: Neurologische Klinik, Brandenburg Klinik Bernau, Brandenburgallee 1
city: Magdeburg
country: Germany
facility: Institut für Medizinische Psychologie, Leipziger Str. 44
Study officials:
affiliation: University of Magdeburg
name: Bernhard A Sabel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: