AphasiaPhase 2NCT01924702
Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)
A Phase 2 study testing Intensive language therapy and transcranial direct current stimulation in people with Aphasia and Anomia (Word-Finding Impairment), run by Charité Neurocure AG Flöel at 1 site in Germany.
Trial summary
The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the outcome of intensive language therapy in chronic aphasia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aphasia, Anomia (Word-Finding Impairment)
- What is being tested?
- Intensive language therapy and transcranial direct current stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2015
- Phase
- Phase 2
- 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
- history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity
- dementia
- contraindications for Magnetic Resonance Imaging or transcranial direct current stimulation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite
Berlin
Robert Darkow, 004930450560395, robert.darkow@charite.de
About this study
The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the outcome of intensive language therapy in chronic aphasia.
Read the detailed description
Stroke is the leading cause of death and disability worldwide. Given the increasing average lifespan worldwide, the incidence and prevalence of patients with stroke will dramatically increase in the future. One of the most frequent and devastating conditions after stroke is aphasia, which affects language production and comprehension. High-frequent intensive speech-and-language therapy is currently the treatment of choice in chronic aphasia. However, despite its general effectiveness, treatment effect sizes are only low to moderate. Thus, there is a pressing need to explore novel training-adjuvant therapies to enhance treatment efficacy. Moreover, very little is known about the neurobiology of treatment-induced recovery in chronic aphasia. This is the prerequisite to improve existing and/or develop new treatment paradigms.
Thus, in the present project the investigators aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. They will be using anodal transcranial direct current stimulation (atDCS) that has previously been shown to enhance (a) language and motor learning in healthy subjects and (b) motor recovery in stroke patients. Specifically, in a longitudinal group comparison design, two matched groups of patients with chronic anomia will receive two weeks of intensive language training with or without atDCS. Treatment effects will be assessed immediately after the two week intervention period and several months after the end of the training. The Investigators will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.
- Conditions
- Aphasia, Anomia (Word-Finding Impairment)
- Being tested
- Intensive language therapy, transcranial direct current stimulation
- Medical subject headings
- Aphasia, Anomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive language therapyBehavioural
2 weeks of daily computerized naming training, daily, 3 hours
transcranial direct current stimulationDevice
1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral
| Study group | Role | What they receive |
|---|---|---|
| anodal tDCS | Active comparator | Intensive language therapy with anodal transcranial direct current stimulation Receives: Behavioral: Intensive language therapy; Device: transcranial direct current stimulation |
| sham tDCS | Sham comparator | Intensive language therapy with Sham-tDCS Receives: Behavioral: Intensive language therapy; Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
naming performance
Measured: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Secondary outcomes (5)
naming performance
Measured: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Naming performance during functional magnetic resonance scanning
Measured: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Naming performance during functional magnetic resonance imaging
Measured: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)
Measured: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)
Measured: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charité Neurocure AG Flöel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnes Floeel, Prof MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924702
- Sponsor's protocol ID
- CATS02EO0801
- Status last verified
- Feb 2015
- First submitted
- 14 Aug 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation (CATS)
- ClinicalTrials.gov ID
- NCT01924702
- Acronym / sponsor ID
- CATS02EO0801
- Conditions
- Aphasia, Anomia (Word-Finding Impairment)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Charité Neurocure AG FlöelUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 16 Aug 2013 (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 purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the outcome of intensive language therapy in chronic aphasia.
Detailed description
Stroke is the leading cause of death and disability worldwide. Given the increasing average lifespan worldwide, the incidence and prevalence of patients with stroke will dramatically increase in the future. One of the most frequent and devastating conditions after stroke is aphasia, which affects language production and comprehension. High-frequent intensive speech-and-language therapy is currently the treatment of choice in chronic aphasia. However, despite its general effectiveness, treatment effect sizes are only low to moderate. Thus, there is a pressing need to explore novel training-adjuvant therapies to enhance treatment efficacy. Moreover, very little is known about the neurobiology of treatment-induced recovery in chronic aphasia. This is the prerequisite to improve existing and/or develop new treatment paradigms.
Thus, in the present project the investigators aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. They will be using anodal transcranial direct current stimulation (atDCS) that has previously been shown to enhance (a) language and motor learning in healthy subjects and (b) motor recovery in stroke patients. Specifically, in a longitudinal group comparison design, two matched groups of patients with chronic anomia will receive two weeks of intensive language training with or without atDCS. Treatment effects will be assessed immediately after the two week intervention period and several months after the end of the training. The Investigators will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anodal tDCS | Active comparator | Behavioral: Intensive language therapy, Device: transcranial direct current stimulationIntensive language therapy with anodal transcranial direct current stimulation |
| sham tDCS | Sham comparator | Behavioral: Intensive language therapy, Device: transcranial direct current stimulationIntensive language therapy with Sham-tDCS |
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 (4 listed)
- more than 1 stroke
- history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity
- dementia
- contraindications for Magnetic Resonance Imaging or transcranial direct current stimulation
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 |
|---|---|---|
| Intensive language therapy2 weeks of daily computerized naming training, daily, 3 hours | Behavioural | anodal tDCS, sham tDCS |
| transcranial direct current stimulation1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral | Device | anodal tDCS, sham tDCS |
Primary outcome
naming performance
Time frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
5 secondary outcomes
naming performance
Time frame: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Naming performance during functional magnetic resonance scanning
Time frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Naming performance during functional magnetic resonance imaging
Time frame: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)
Time frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Changes on the Amsterdam Nijmegen Everyday Language Test (ANELT)
Time frame: Change of naming score from post-testing (after end of intervention) to 3 months after the intervention (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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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.
Agnes Floeel, Prof MD principal investigator
Charite University, 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 study testing Intensive language therapy and transcranial direct current stimulation in people with Aphasia and Anomia (Word-Finding Impairment), run by Charité Neurocure AG Flöel 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 4 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 4 Feb 2015. 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 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.
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 Robert Darkow (004930450560395, robert.darkow@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
naming performance (time frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)). 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 4 Feb 2015.