A Phase 3 interventional study of rtACS stimulation (Verum condition) and placebo condition in Aphasia, sponsored by University of Magdeburg. Terminated at 3 sites in Germany. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-12-19.
Sponsored by University of Magdeburg · Phase 3, Interventional, and Treatment
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.
365 studies on the registry are indexed under Aphasia; 89 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 316 interventional studies indexed under Aphasia.
Browse Aphasia studies →University of Magdeburg is the lead sponsor of 33 studies on the registry; none are open to participants now.
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Exclusion Criteria:
repetitive transorbital alternating current stimulation (rtACS)
Device: rtACS stimulation (Verum condition)
Sham stimulation (placebo condition) no intervention
Device: placebo condition
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
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).
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
Time frame: between baseline and 60 days after stimulation
successful stabilization of language
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: baseline to 60 days after stimulation
This study is terminated, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.
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University of Magdeburg