AphasiaPhase 3NCT01277575
Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia
A Phase 3 study testing rtACS stimulation (Verum condition) in people with Aphasia, run by University of Magdeburg at 3 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Aphasia
- What is being tested?
- rtACS stimulation (Verum condition)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesGermany
- Study dates
- Dec 2010to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Neurologische Klinik, Medizinische Fakultät der RWTH Aachen, Pauwelsstr. 30
Aachen, 52074
Neurologische Klinik, Brandenburg Klinik Bernau, Brandenburgallee 1
Bernau Waldsiedlung, 16321
Institut für Medizinische Psychologie, Leipziger Str. 44
Magdeburg, 39120
About this study
Official title: 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.
- Conditions
- Aphasia
- Being tested
- rtACS stimulation (Verum condition), placebo condition
- Keywords
- stroke, aphasia, language
- Medical subject headings
- Aphasia, Stroke, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
placebo conditionDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Verum stimulation | Experimental | repetitive transorbital alternating current stimulation (rtACS) Receives: Device: rtACS stimulation (Verum condition) |
| Placebo stimulation | Sham comparator | Sham stimulation (placebo condition) no intervention Receives: Device: placebo condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: between baseline and 60 days after stimulation
Secondary outcomes (6)
successful stabilization of language
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline to 60 days after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: recruitment efforts did not result in a sufficient number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Collaborators
- EBS Technologies GmbH
- Investigators
- Bernhard A Sabel, Prof. Dr., Principal investigator, University of Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277575
- Sponsor's protocol ID
- EBS-PP-2010-08-25-001
- Status last verified
- Jan 2011
- First submitted
- 14 Jan 2011
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Non-invasive Repetitive Paraorbital Alternating Current Stimulation of the Brain: Therapy for Aphasy
- ClinicalTrials.gov ID
- NCT01277575
- Acronym / sponsor ID
- EBS-PP-2010-08-25-001
- Conditions
- Aphasia
- Keywords
- stroke, aphasia, language
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment efforts did not result in a sufficient number of patients
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- EBS Technologies GmbH
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum stimulation | Experimental | Device: rtACS stimulation (Verum condition)repetitive transorbital alternating current stimulation (rtACS) |
| Placebo stimulation | Sham comparator | Device: placebo conditionSham stimulation (placebo condition) no intervention |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Verum stimulation |
| placebo conditionA 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). | Device | Placebo stimulation |
Primary outcome
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
6 secondary outcomes
successful stabilization of language
Time frame: 60 days after stimulation
speaking functions 1 - communicative skills
Time frame: baseline to 60 days after stimulation
speaking functions 2 - spontaneous speech faculty
Time frame: baseline to 60 days after stimulation
speaking functions 3 - naming
Time frame: baseline to 60 days after stimulation
speaking functions 4 - repeating
Time frame: baseline to 60 days after stimulation
speaking functions 5 - understanding
Time frame: baseline to 60 days after stimulation
Results and safety
The study was stopped early (reason given: recruitment efforts did not result in a sufficient number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernhard A Sabel, Prof. Dr. principal investigator
University of Magdeburg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rtACS stimulation (Verum condition) in people with Aphasia, run by University of Magdeburg at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recruitment efforts did not result in a sufficient number of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of speaking (time frame: between baseline and 60 days after stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.