AphasiaPhase 2/3NCT00822068
Improvement of Language Disturbances After Stroke by Intensive Training and Electrical Brain Stimulation
A Phase 2/3 study testing anodal tDCS and cathodal tDCS in people with Aphasia and Stroke, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The study aims to identify if intensive language training, consisting mainly of computer-based object naming, together with electrical brain stimulation, will lead to an improvement of language functions in patients that suffer from language disturbances after a stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- anodal tDCS and cathodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Dec 2009
- Phase
- Phase 2/3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic stroke (> 1 year after event)
- aphasia due to stroke with naming impairment
- German as first language
- first-ever stroke
Who cannot join
- more than 1 stroke
- progressive stroke
- history of severe alcohol or drug abuse, psychiatric illnessess like severe depression, poor motivational capacity
- dementia
- contraindications for Magnetic Resonance Imaging
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, University of Muenster; Department of Neurology, University of Berlin
Muenster / Berlin, NRW/Berlin-Brandenburg, 48129/10098
Agnes Floel, MD, +49 251 83 ext. 45699, floeel@uni-muenster.de
Caterina Breiteinstein, PhD, breitens@uni-muenster.de
About this study
Official title: Improvement of Aphasia After Stroke by Intensive Training and Transcranial Direct Current Stimulation
The study aims to identify if intensive language training, consisting mainly of computer-based object naming, together with electrical brain stimulation, will lead to an improvement of language functions in patients that suffer from language disturbances after a stroke.
- Being tested
- anodal tDCS, cathodal tDCS, sham stimulation
- Keywords
- stroke, aphasia, rehabilitation, transcranial direct current stimulation, intensive training, chronic aphasia after stroke
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anodal tDCSDevice
anodal transcranial direct current stimulation
cathodal tDCSDevice
cathodal transcranial direct current stimulation
sham stimulationDevice
sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS | Experimental | Not described Receives: Device: anodal tDCS |
| 2 | Active comparator | cathodal tDCS Receives: Device: cathodal tDCS |
| 3 | Placebo comparator | sham stimulation Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of words correctly named after training plus tDCS
Measured: 1 year
Secondary outcomes (1)
Communicative-Activity-Log & Stroke-and-Aphasia-Quality-of-Life-Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Agnes Floel, MD, Principal investigator, Department of Neurology, University of Muenster; Department of Neurology, University of Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822068
- Sponsor's protocol ID
- Aphasia_tDCS
- Status last verified
- Jan 2009
- First submitted
- 13 Jan 2009
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Floel A, Meinzer M, Kirstein R, Nijhof S, Deppe M, Knecht S, Breitenstein C. Short-term anomia training and electrical brain stimulation. Stroke. 2011 Jul;42(7):2065-7. doi: 10.1161/STROKEAHA.110.609032. Epub 2011 Jun 2.
PubMed 21636820
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Aphasia After Stroke by Intensive Training and Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT00822068
- Acronym / sponsor ID
- Aphasia_tDCS
- Keywords
- stroke, aphasia, rehabilitation, transcranial direct current stimulation, intensive training, chronic aphasia after stroke
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 14 Jan 2009 (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 study aims to identify if intensive language training, consisting mainly of computer-based object naming, together with electrical brain stimulation, will lead to an improvement of language functions in patients that suffer from language disturbances after a stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS | Experimental | Device: anodal tDCS |
| 2 | Active comparator | Device: cathodal tDCScathodal tDCS |
| 3 | Placebo comparator | Device: sham stimulationsham stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic stroke (> 1 year after event)
- aphasia due to stroke with naming impairment
- German as first language
- first-ever stroke
Key exclusion criteria (5 listed)
- more than 1 stroke
- progressive stroke
- history of severe alcohol or drug abuse, psychiatric illnessess like severe depression, poor motivational capacity
- dementia
- contraindications for Magnetic Resonance Imaging
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 |
|---|---|---|
| anodal tDCSanodal transcranial direct current stimulation | Device | anodal tDCS |
| cathodal tDCScathodal transcranial direct current stimulation | Device | 2 |
| sham stimulationsham stimulation | Device | 3 |
Primary outcome
Number of words correctly named after training plus tDCS
Time frame: 1 year
1 secondary outcome
Communicative-Activity-Log & Stroke-and-Aphasia-Quality-of-Life-Scale
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2009.
- Derived from this study: PubMed 21636820Floel A, Meinzer M, Kirstein R, Nijhof S, Deppe M, Knecht S, Breitenstein C. Short-term anomia training and electrical brain stimulation. Stroke. 2011 Jul;42(7):2065-7. doi: 10.1161/STROKEAHA.110.609032. Epub 2011 Jun 2.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Agnes Floel, MD principal investigator
Department of Neurology, University of Muenster; Department of Neurology, University of Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing anodal tDCS and cathodal tDCS in people with Aphasia and Stroke, run by University Hospital Muenster at 1 site 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agnes Floel, MD (0049 251 83 ext. 45699, floeel@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of words correctly named after training plus tDCS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00822068, which also lists 1 linked publication.
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 14 Jan 2009.