Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

December 18, 2013 updated by: University of Magdeburg

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Neurologische Klinik, Medizinische Fakultät der RWTH Aachen, Pauwelsstr. 30
      • Bernau Waldsiedlung, Germany, 16321
        • Neurologische Klinik, Brandenburg Klinik Bernau, Brandenburgallee 1
      • Magdeburg, Germany, 39120
        • Institut für Medizinische Psychologie, Leipziger Str. 44

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Verum stimulation
repetitive transorbital alternating current stimulation (rtACS)
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
SHAM_COMPARATOR: Placebo stimulation
Sham stimulation (placebo condition) no intervention
Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement of speaking
Time Frame: between baseline and 60 days after stimulation

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
successful stabilization of language
Time Frame: 60 days after stimulation
60 days after stimulation
speaking functions 1 - communicative skills
Time Frame: baseline to 60 days after stimulation
  • 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
speaking functions 2 - spontaneous speech faculty
Time Frame: baseline to 60 days after stimulation
  • 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
speaking functions 3 - naming
Time Frame: baseline to 60 days after stimulation
  • 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
speaking functions 4 - repeating
Time Frame: baseline to 60 days after stimulation
  • 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
speaking functions 5 - understanding
Time Frame: baseline to 60 days after stimulation
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Magdeburg

Collaborators

EBS Technologies GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (ESTIMATE)

January 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBS-PP-2010-08-25-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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