HealthyPhase 4NCT00102284
Neuromodulation and Language Acquisition (Project Stage Ia)
A Phase 4 study testing levodopa, rivastigmine and pergolid in people with Healthy, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether levodopa, pergolid, rivastigmine, or modafinil are effective in boosting semantic language acquisition in healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- levodopa, rivastigmine and pergolid
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2004to Apr 2005
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- 20-35 years old
- Right handedness
- Left language dominance (as assessed by functional transcranial Doppler ultrasonography [fTCD])
Who cannot join
- Neurological/psychiatric/metabolic/cardiac disorders
- Asthma
- Known allergic reactions to one of the experimental drugs
- Other drugs affecting the central nervous system
- Leisure drug ingestion during the past 4 weeks (urine test)
- Smoking cessation during the past 2 weeks
Show all 9Show fewer
- > 6 cups of coffee or energy drinks per day
- > 10 cigarettes per day
- > 50 grams of alcohol per day
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: Improved Language Acquisition Through Neuromodulation, Project Stage Ia
The purpose of this study is to determine whether levodopa, pergolid, rivastigmine, or modafinil are effective in boosting semantic language acquisition in healthy subjects.
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 a mixed d1/d2 dopamine agonist (pergolid) or cholinergic neuromodulation (rivastigmine) or a general centrally arousing substance (modafinil) will yield a learning enhancement comparable to using levodopa in healthy subjects.
Our results show that the dopamine agonist pergolide impaired learning in healthy subjects compared to placebo, whereas cholinergic neuromodulation had no effect.
- Conditions
- Healthy
- Being tested
- levodopa, rivastigmine, pergolid, modafinil
- Keywords
- language acquisition, plasticity, stroke recovery, associative learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopaDrug
rivastigmineDrug
pergolidDrug
modafinilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Boost in language learning success through neuromodulation
Secondary outcomes (1)
Stability of language learning success
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2005 (estimated)
- Study startMar 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Caterina Breitenstein, PhD, Study director, Dept. of Neurology, University Hospital MuensterStefan Knecht, MD, Study chair, Dept. of Neurology, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102284
- Sponsor's protocol ID
- KS-NEUROMOD_01, Stage Ia
- Other IDs
- IZKF Muenster: Kne3/074/04
- Status last verified
- Sep 2006
- First submitted
- 26 Jan 2005
- Last updated
- 27 Jan 2010
- Results posted
- No
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, Floel A, Korsukewitz C, Wailke S, Bushuven S, Knecht S. A shift of paradigm: from noradrenergic to dopaminergic modulation of learning? J Neurol Sci. 2006 Oct 25;248(1-2):42-7. doi: 10.1016/j.jns.2006.05.012. Epub 2006 Jul 11.
PubMed 16815467Korsukewitz C, Breitenstein C, Schomacher M, Knecht S. [Present status and future possibilities of adjuvant pharmacotherapy for aphasia]. Nervenarzt. 2006 Apr;77(4):403-15. doi: 10.1007/s00115-005-2006-6. German.
PubMed 16273340Breitenstein C, Korsukewitz C, Floel A, Kretzschmar T, Diederich K, Knecht S. Tonic dopaminergic stimulation impairs associative learning in healthy subjects. Neuropsychopharmacology. 2006 Nov;31(11):2552-64. doi: 10.1038/sj.npp.1301167. Epub 2006 Jul 26.
PubMed 16880771
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Language Acquisition Through Neuromodulation, Project Stage Ia
- ClinicalTrials.gov ID
- NCT00102284
- Acronym / sponsor ID
- KS-NEUROMOD_01, Stage Ia
- Conditions
- Healthy
- Keywords
- language acquisition, plasticity, stroke recovery, associative learning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Apr 2005
- First posted
- 27 Jan 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, pergolid, rivastigmine, or modafinil are effective in boosting semantic language acquisition in healthy subjects.
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 a mixed d1/d2 dopamine agonist (pergolid) or cholinergic neuromodulation (rivastigmine) or a general centrally arousing substance (modafinil) will yield a learning enhancement comparable to using levodopa in healthy subjects.
Our results show that the dopamine agonist pergolide impaired learning in healthy subjects compared to placebo, whereas cholinergic neuromodulation had no effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects
- 20-35 years old
- Right handedness
- Left language dominance (as assessed by functional transcranial Doppler ultrasonography [fTCD])
Key exclusion criteria (9 listed)
- Neurological/psychiatric/metabolic/cardiac disorders
- Asthma
- Known allergic reactions to one of the experimental drugs
- Other drugs affecting the central nervous system
- Leisure drug ingestion during the past 4 weeks (urine test)
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 |
|---|---|---|
| levodopa | Drug | – |
| rivastigmine | Drug | – |
| pergolid | Drug | – |
| modafinil | Drug | – |
Primary outcome
Boost in language learning success through neuromodulation
1 secondary outcome
Stability of language learning success
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2010.
- 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 16815467Breitenstein C, Floel A, Korsukewitz C, Wailke S, Bushuven S, Knecht S. A shift of paradigm: from noradrenergic to dopaminergic modulation of learning? J Neurol Sci. 2006 Oct 25;248(1-2):42-7. doi: 10.1016/j.jns.2006.05.012. Epub 2006 Jul 11.
- Background: PubMed 16273340Korsukewitz C, Breitenstein C, Schomacher M, Knecht S. [Present status and future possibilities of adjuvant pharmacotherapy for aphasia]. Nervenarzt. 2006 Apr;77(4):403-15. doi: 10.1007/s00115-005-2006-6. German.
- Results publication: PubMed 16880771Breitenstein C, Korsukewitz C, Floel A, Kretzschmar T, Diederich K, Knecht S. Tonic dopaminergic stimulation impairs associative learning in healthy subjects. Neuropsychopharmacology. 2006 Nov;31(11):2552-64. doi: 10.1038/sj.npp.1301167. Epub 2006 Jul 26.
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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
Stefan Knecht, MD study chair
Dept. of Neurology, University Hospital Muenster
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, rivastigmine and pergolid in people with Healthy, 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 9 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 27 Jan 2010. 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 was stopped early. 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?
Boost in language learning success through neuromodulation. 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 NCT00102284, which also lists 5 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 27 Jan 2010.