search
Back to results

Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

Primary Purpose

Aphasia

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
rtACS stimulation (Verum condition)
placebo condition
Sponsored by
University of Magdeburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring stroke, aphasia, language

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurologische Klinik, Medizinische Fakultät der RWTH Aachen, Pauwelsstr. 30
  • Neurologische Klinik, Brandenburg Klinik Bernau, Brandenburgallee 1
  • Institut für Medizinische Psychologie, Leipziger Str. 44

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Verum stimulation

Placebo stimulation

Arm Description

repetitive transorbital alternating current stimulation (rtACS)

Sham stimulation (placebo condition) no intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

successful stabilization of language
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)
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)
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)
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)
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)

Full Information

First Posted
January 14, 2011
Last Updated
December 18, 2013
Sponsor
University of Magdeburg
Collaborators
EBS Technologies GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT01277575
Brief Title
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

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
recruitment efforts did not result in a sufficient number of patients
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Magdeburg
Collaborators
EBS Technologies GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
stroke, aphasia, language

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Verum stimulation
Arm Type
Experimental
Arm Description
repetitive transorbital alternating current stimulation (rtACS)
Arm Title
Placebo stimulation
Arm Type
Sham Comparator
Arm Description
Sham stimulation (placebo condition) no intervention
Intervention Type
Device
Intervention Name(s)
rtACS stimulation (Verum condition)
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
placebo condition
Intervention Description
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).
Primary Outcome Measure Information:
Title
improvement of speaking
Description
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
Secondary Outcome Measure Information:
Title
successful stabilization of language
Time Frame
60 days after stimulation
Title
speaking functions 1 - communicative skills
Description
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
Title
speaking functions 2 - spontaneous speech faculty
Description
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
Title
speaking functions 3 - naming
Description
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
Title
speaking functions 4 - repeating
Description
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
Title
speaking functions 5 - understanding
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard A Sabel, Prof. Dr.
Organizational Affiliation
University of Magdeburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neurologische Klinik, Medizinische Fakultät der RWTH Aachen, Pauwelsstr. 30
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Neurologische Klinik, Brandenburg Klinik Bernau, Brandenburgallee 1
City
Bernau Waldsiedlung
ZIP/Postal Code
16321
Country
Germany
Facility Name
Institut für Medizinische Psychologie, Leipziger Str. 44
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

We'll reach out to this number within 24 hrs