Post-Stroke Chronic AphasiaPhase 2CATSNCT01221779
Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation
A Phase 2 study testing Intensive language therapy in people with Post-Stroke Chronic Aphasia and Anomia (Word-retrieval Impairment), run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the out of intensive language therapy in chronic aphasia Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-Stroke Chronic Aphasia, Anomia (Word-retrieval Impairment)
- What is being tested?
- Intensive language therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Dec 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- right-handedness
- single first time left-hemisphere stroke
- fluent- or non-fluent chronic aphasia (more than six months post-stroke)
- anomia (PR>10 and PR<60 Aachen Aphasia Naming Subtest)
- native German Speaker
Who cannot join
- more than one stroke
- alcoholism, severe psychiatric conditions, other neurological conditions
- other non-treated medical problems, severe microangiopathy
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite, University Medicine, Dept. of Neurology
Berlin
Marcus Meinzer, PhD
Agnes Flöel, MD
About this study
Official title: Chronic Aphasia - Improved by Intensive Training and Electrical Brain
The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the out 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 we aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. We 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. We will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.
- Being tested
- Intensive language therapy
- Keywords
- Intensive language therapy, Anomia, Magnetic Resonance Imaging
- Medical subject headings
- 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
Intensive language therapyBehavioural
2 weeks of daily computerized naming training, daily, 3 hours
| Study group | Role | What they receive |
|---|---|---|
| sham tDCS | Placebo comparator | Not described Receives: Behavioral: Intensive language therapy |
| anodal tDCS | Experimental | Not described Receives: Behavioral: Intensive language therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Naming Test
Measured: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
Secondary outcomes (3)
Boston Naming Test
The follow-up will be administered to assess the stability of the treatment gains
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
assessed during overt picture naming task
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
assessed during overt picture naming task
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 posted15 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Stroke Chronic AphasiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Marcus Meinzer, Charite University, Berlin, Germany
- Investigators
- Marcus Meinzer, PhD, Principal investigator, Charite, University Medicine, NeurologyAgnes Flöel, MD, Study director, Charite, University Medicine, Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221779
- Sponsor's protocol ID
- CATS01EO0801
- Acronym
- CATS
- Status last verified
- Aug 2013
- First submitted
- 13 Oct 2010
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Aphasia - Improved by Intensive Training and Electrical Brain
- ClinicalTrials.gov ID
- NCT01221779
- Acronym / sponsor ID
- CATS / CATS01EO0801
- Keywords
- Intensive language therapy, Anomia, Magnetic Resonance Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 15 Oct 2010 (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 out 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 we aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. We 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. We 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 |
|---|---|---|
| sham tDCS | Placebo comparator | Behavioral: Intensive language therapy |
| anodal tDCS | Experimental | Behavioral: Intensive language therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- right-handedness
- single first time left-hemisphere stroke
- fluent- or non-fluent chronic aphasia (more than six months post-stroke)
- anomia (PR>10 and PR<60 Aachen Aphasia Naming Subtest)
- native German Speaker
Key exclusion criteria (4 listed)
- more than one stroke
- alcoholism, severe psychiatric conditions, other neurological conditions
- other non-treated medical problems, severe microangiopathy
- pregnancy
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 | sham tDCS |
| Intensive language therapy2 weeks of daily computerized naming training, daily, 3 hours | Behavioural | anodal tDCS |
Primary outcome
Boston Naming Test
Time frame: Change of naming score from baseline (day 1 of study) to immediately after 2-week intervention period (post-testing)
3 secondary outcomes
Boston Naming Test
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 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.
Marcus Meinzer, PhD principal investigator
Charite, University Medicine, Neurology
Agnes Flöel, MD study director
Charite, University Medicine, Neurology
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 in people with Post-Stroke Chronic Aphasia and Anomia (Word-retrieval Impairment), run by Charite University, Berlin, Germany 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 5 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 27 Aug 2013. 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 Marcus Meinzer, PhD (+49-(0)30-450-560 ext. 140, marcus.meinzer@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Naming Test (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 27 Aug 2013.