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recruitment efforts did not result in a sufficient number of patients
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| Name | Class |
|---|---|
| EBS Technologies GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum stimulation | Experimental | repetitive transorbital alternating current stimulation (rtACS) |
|
| Placebo stimulation | Sham Comparator | Sham stimulation (placebo condition) no intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rtACS stimulation (Verum condition) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| improvement of speaking | assessed by the following tests:
| between baseline and 60 days after stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| successful stabilization of language | 60 days after stimulation | |
| speaking functions 1 - communicative skills |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard A Sabel, Prof. Dr. | University of Magdeburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurologische Klinik, Medizinische Fakultät der RWTH Aachen, Pauwelsstr. 30 | Aachen | 52074 | Germany | |||
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| ID | Term |
|---|---|
| D001037 | Aphasia |
| D020521 | Stroke |
| D007802 | Language |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
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|
| placebo condition | Device | 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). |
|
| baseline to 60 days after stimulation |
| speaking functions 2 - spontaneous speech faculty |
| baseline to 60 days after stimulation |
| speaking functions 3 - naming |
| baseline to 60 days after stimulation |
| speaking functions 4 - repeating |
| baseline to 60 days after stimulation |
| speaking functions 5 - understanding |
| baseline to 60 days after stimulation |
| Neurologische Klinik, Brandenburg Klinik Bernau, Brandenburgallee 1 |
| Bernau Waldsiedlung |
| 16321 |
| Germany |
| Institut für Medizinische Psychologie, Leipziger Str. 44 | Magdeburg | 39120 | Germany |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003142 | Communication |
| D001519 | Behavior |