Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

Aphasia Clinical Trial

Official title:

Multicenter Study of Non-invasive Repetitive Paraorbital Alternating Current Stimulation of the Brain: Therapy for Aphasy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01277575
• Other study ID #: EBS-PP-2010-08-25-001
• Status: Terminated
• Phase: Phase 3
• First received: January 14, 2011
• Last updated: December 18, 2013
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2011
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia

Intervention

Device:
• rtACS stimulation (Verum 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
• placebo condition
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).

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Magdeburg	EBS Technologies GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	between baseline and 60 days after stimulation	No
Secondary	successful stabilization of language		60 days after stimulation	No
Secondary	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)	baseline to 60 days after stimulation	No
Secondary	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)	baseline to 60 days after stimulation	No
Secondary	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)	baseline to 60 days after stimulation	No
Secondary	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)	baseline to 60 days after stimulation	No
Secondary	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)	baseline to 60 days after stimulation	No