Cerebrovascular AccidentPhase 4NCT00102869
Dopaminergic Enhancement of Learning and Memory in Aphasia
A Phase 4 study testing levodopa in people with Cerebrovascular Accident and Aphasia, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether levodopa, in combination with a high frequency language training, is effective in boosting naming performance in patients with aphasia. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident, Aphasia
- What is being tested?
- levodopa
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Dec 2008
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral cerebrovascular accident (stroke) in the territory of the arteria media
- Time post onset: > 6 months
- Aphasia with anomia
- Age between 18-75 years
- Premorbid right-handedness
- Primary language: German
Who cannot join
- Known allergy to levodopa or tartrazine
- History of medication/drug abuse
- Acute nicotine withdrawal or > 15 cigarettes per day
- > 6 cups/glasses of coffee, caffeine drinks or energy drinks per day
- > 50 grams of alcohol per day
- Severe hypertonia (systole >180 mm Hg)
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- Severe arteriosclerosis
- Diabetes, asthma, or glaucoma
- Severe hearing disability
- Evidence for severe hippocampal damage
- Premorbid depression or psychosis
- Medication with dopamine agonists or antagonists
- Parkinsonian symptoms
- Changes in anticonvulsive medication during the week prior to study enrollment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Neurology, University Hospital Muenster
Münster, North Rhine-Westphalia, 48129
About this study
Official title: Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)
The purpose of this study is to determine whether levodopa, in combination with a high frequency language training, is effective in boosting naming performance in patients with aphasia.
Read the detailed description
Our prior work shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether daily administration of levodopa, coupled with several hours of language training every day, will significantly improve naming abilities in patients with aphasia as compared to placebo administration. We furthermore examine with magnetic resonance imaging which brain regions need to be functionally intact for a dopaminergic improvement of language therapy.
- Conditions
- Cerebrovascular Accident, Aphasia
- Being tested
- levodopa
- Keywords
- language acquisition, plasticity, stroke recovery, aphasia treatment, naming, levodopa, stroke
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopaDrug
100mg levodopa per day over 10 days/ treatment phase
What is being measured
The primary outcome is the main question the study is designed to answer.
Boost in naming performance (percent correct) through levodopa as compared to placebo
Measured: immediately after each treatmentphase
Brain activity pattern in successfully trained patients
Measured: immediately after each treatmentphase
Secondary outcomes (1)
Stability of naming performance after one month and six months post treatment
Measured: from 1 month untill 6 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2005 (estimated)
- Study startJan 2005
- Primary completionFeb 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Caterina Breitenstein, PhD, Study director, Dept. of Neurology, University Hospital Muenster, GermanyStefan Knecht, MD, Study chair, Dept. of Neurology, University Hospital Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102869
- Sponsor's protocol ID
- LL_001, Project on aphasia
- Status last verified
- Jun 2008
- First submitted
- 3 Feb 2005
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. doi: 10.1002/ana.20125.
PubMed 15236398Breitenstein C, Wailke S, Bushuven S, Kamping S, Zwitserlood P, Ringelstein EB, Knecht S. D-amphetamine boosts language learning independent of its cardiovascular and motor arousing effects. Neuropsychopharmacology. 2004 Sep;29(9):1704-14. doi: 10.1038/sj.npp.1300464.
PubMed 15114342Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German.
PubMed 12596014Breitenstein C, Korsukewitz C, Baumgartner A, Floel A, Zwitserlood P, Dobel C, Knecht S. L-dopa does not add to the success of high-intensity language training in aphasia. Restor Neurol Neurosci. 2015;33(2):115-20. doi: 10.3233/RNN-140435.
PubMed 25588456
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Aphasia)
- ClinicalTrials.gov ID
- NCT00102869
- Acronym / sponsor ID
- LL_001, Project on aphasia
- Conditions
- Cerebrovascular Accident, Aphasia
- Keywords
- language acquisition, plasticity, stroke recovery, aphasia treatment, naming, levodopa, stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jan 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Feb 2005 (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 whether levodopa, in combination with a high frequency language training, is effective in boosting naming performance in patients with aphasia.
Detailed description
Our prior work shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether daily administration of levodopa, coupled with several hours of language training every day, will significantly improve naming abilities in patients with aphasia as compared to placebo administration. We furthermore examine with magnetic resonance imaging which brain regions need to be functionally intact for a dopaminergic improvement of language therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral cerebrovascular accident (stroke) in the territory of the arteria media
- Time post onset: > 6 months
- Aphasia with anomia
- Age between 18-75 years
- Premorbid right-handedness
Key exclusion criteria (14 listed)
- Known allergy to levodopa or tartrazine
- History of medication/drug abuse
- Acute nicotine withdrawal or > 15 cigarettes per day
- > 6 cups/glasses of coffee, caffeine drinks or energy drinks per day
- > 50 grams of alcohol per day
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 |
|---|---|---|
| levodopa100mg levodopa per day over 10 days/ treatment phase | Drug | – |
Primary outcome
Boost in naming performance (percent correct) through levodopa as compared to placebo
Time frame: immediately after each treatmentphase
Brain activity pattern in successfully trained patients
Time frame: immediately after each treatmentphase
1 secondary outcome
Stability of naming performance after one month and six months post treatment
Time frame: from 1 month untill 6 months after treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
- Background: PubMed 15236398Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. doi: 10.1002/ana.20125.
- Background: PubMed 15114342Breitenstein C, Wailke S, Bushuven S, Kamping S, Zwitserlood P, Ringelstein EB, Knecht S. D-amphetamine boosts language learning independent of its cardiovascular and motor arousing effects. Neuropsychopharmacology. 2004 Sep;29(9):1704-14. doi: 10.1038/sj.npp.1300464.
- Background: PubMed 12596014Breitenstein C, Knecht S. [Language acquisition and statistical learning]. Nervenarzt. 2003 Feb;74(2):133-43. doi: 10.1007/s00115-002-1466-1. German.
- Derived from this study: PubMed 25588456Breitenstein C, Korsukewitz C, Baumgartner A, Floel A, Zwitserlood P, Dobel C, Knecht S. L-dopa does not add to the success of high-intensity language training in aphasia. Restor Neurol Neurosci. 2015;33(2):115-20. doi: 10.3233/RNN-140435.
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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.
Caterina Breitenstein, PhD study director
Dept. of Neurology, University Hospital Muenster, Germany
Stefan Knecht, MD study chair
Dept. of Neurology, University Hospital Muenster, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levodopa in people with Cerebrovascular Accident and Aphasia, 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 6 inclusion and 14 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: finished, as of the sponsor's last update on 7 Oct 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Boost in naming performance (percent correct) through levodopa as compared to placebo (time frame: immediately after each treatmentphase). The study lists 2 primary outcomes in all. 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 NCT00102869, which also lists 4 linked publications.
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 7 Oct 2013.