StrokePhase 4NCT00126087
Potentiation of Procedural Motor Learning in Health and Disease
A Phase 4 study testing dopamine in people with Stroke, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The investigators plan to improve the learning of motor skills by pharmacological means (dopamine), and by noninvasive brain stimulation. They will study both healthy subjects and chronic stroke patients. In addition, they want to study the mechanisms of enhanced learning, on the molecular and the systems level. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- dopamine
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2005to Jan 2013
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers:
- Normal neurological examination
- Mini Mental State Examination of > 27
- Right handedness
- Stroke Patients:
- Cortical or subcortical stroke with an initial severe hemiparesis Medical Research Council (MRC) scale < 2 that has recovered to a degree that patients are able to perform the proposed task (in general > MRC 4.5, with low spasticity, work in progress on motor learning in stroke patients)
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- At least 1 year post-stroke
- Mini Mental State Examination of > 27
- Right-handedness
Who cannot join
- Healthy Volunteers and Stroke Patients:
- No antipsychotic, antidepressant drugs, and drugs affecting the dopaminergic system.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Münster, Department of Neurology
Münster, North Rhine-Westphalia, 48129
About this study
Official title: Potentiation of Procedural Motor Learning by Pharmacological Neuromodulation and Transcranial Direct Current Stimulation in Health and Disease
The investigators plan to improve the learning of motor skills by pharmacological means (dopamine), and by noninvasive brain stimulation. They will study both healthy subjects and chronic stroke patients. In addition, they want to study the mechanisms of enhanced learning, on the molecular and the systems level.
Read the detailed description
Adaptive behavior requires procedural motor learning, i.e. the acquisition of motor skills. Procedural learning is particularly critical in the rehabilitation of chronic motor deficits after stroke. A potent modulator of motor function and learning is found in the endogenous dopaminergic system. The investigator's own work could demonstrate that formation of an elementary motor memory, which constitutes the first step in acquiring more complex motor skills, can be enhanced in both healthy subjects and chronic stroke patients by pre-medication with levodopa. The aim of the present proposal is to:
- expand these exciting findings to procedural motor learning;
- explore the interaction with age, brain lesions, add-on interventions such as transcranial direct current stimulation (tDCS); and
- illuminate the underlying mechanisms.
The effect of levodopa +/- tDCS on procedural motor learning and cortical excitability will be studied in healthy volunteers and stroke patients. Then the investigator plans to delineate the underlying mechanisms of this effect by exploring N-methyl-D-asparate (NMDA) receptor-dependency of levodopa-enhanced learning and changes in activation and connectivity (using functional magnetic resonance imaging) in the respective neural networks resulting from the interaction of learning and dopaminergic neuromodulation.
- Conditions
- Stroke
- Being tested
- dopamine
- Keywords
- dopamine, NMDA receptor, brain imaging, neuroplasticity, learning, transcranial direct current stimulation, rehabilitation, aging
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dopamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural motor learning (decrease in reaction time in ms) after the respective intervention (dopamine, transcranial direct current stimulation), compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionDec 2007
- Study completionJan 2013
Why it stopped: no further funding available for recruiting and testing participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnes Flöel, MD, Principal investigator, University of Münster, Department of Neurology, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126087
- Sponsor's protocol ID
- Motor-Neuromod_01
- Status last verified
- Jan 2013
- First submitted
- 31 Jul 2005
- Last updated
- 21 Jan 2013
- Results posted
- No
Publications
Floel A, Breitenstein C, Hummel F, Celnik P, Gingert C, Sawaki L, Knecht S, Cohen LG. Dopaminergic influences on formation of a motor memory. Ann Neurol. 2005 Jul;58(1):121-30. doi: 10.1002/ana.20536.
PubMed 15984008Rosser N, Heuschmann P, Wersching H, Breitenstein C, Knecht S, Floel A. Levodopa improves procedural motor learning in chronic stroke patients. Arch Phys Med Rehabil. 2008 Sep;89(9):1633-41. doi: 10.1016/j.apmr.2008.02.030.
PubMed 18760148
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potentiation of Procedural Motor Learning by Pharmacological Neuromodulation and Transcranial Direct Current Stimulation in Health and Disease
- ClinicalTrials.gov ID
- NCT00126087
- Acronym / sponsor ID
- Motor-Neuromod_01
- Conditions
- Stroke
- Keywords
- dopamine, NMDA receptor, brain imaging, neuroplasticity, learning, transcranial direct current stimulation, rehabilitation, aging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no further funding available for recruiting and testing participants
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Aug 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 investigators plan to improve the learning of motor skills by pharmacological means (dopamine), and by noninvasive brain stimulation. They will study both healthy subjects and chronic stroke patients. In addition, they want to study the mechanisms of enhanced learning, on the molecular and the systems level.
Detailed description
Adaptive behavior requires procedural motor learning, i.e. the acquisition of motor skills. Procedural learning is particularly critical in the rehabilitation of chronic motor deficits after stroke. A potent modulator of motor function and learning is found in the endogenous dopaminergic system. The investigator's own work could demonstrate that formation of an elementary motor memory, which constitutes the first step in acquiring more complex motor skills, can be enhanced in both healthy subjects and chronic stroke patients by pre-medication with levodopa. The aim of the present proposal is to:
- expand these exciting findings to procedural motor learning;
- explore the interaction with age, brain lesions, add-on interventions such as transcranial direct current stimulation (tDCS); and
- illuminate the underlying mechanisms.
The effect of levodopa +/- tDCS on procedural motor learning and cortical excitability will be studied in healthy volunteers and stroke patients. Then the investigator plans to delineate the underlying mechanisms of this effect by exploring N-methyl-D-asparate (NMDA) receptor-dependency of levodopa-enhanced learning and changes in activation and connectivity (using functional magnetic resonance imaging) in the respective neural networks resulting from the interaction of learning and dopaminergic neuromodulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Normal neurological examination
- Mini Mental State Examination of > 27
- Right handedness
- Cortical or subcortical stroke with an initial severe hemiparesis Medical Research Council (MRC) scale < 2 that has recovered to a degree that patients are able to perform the proposed task (in general > MRC 4.5, with low spasticity, work in progress on motor learning in stroke patients)
- At least 1 year post-stroke
Key exclusion criteria (2 listed)
- No antipsychotic, antidepressant drugs, and drugs affecting the dopaminergic system.
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 |
|---|---|---|
| dopamine | Drug | – |
Primary outcome
Procedural motor learning (decrease in reaction time in ms) after the respective intervention (dopamine, transcranial direct current stimulation), compared to placebo
Results and safety
The study was stopped early (reason given: no further funding available for recruiting and testing participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2013.
- Background: PubMed 15984008Floel A, Breitenstein C, Hummel F, Celnik P, Gingert C, Sawaki L, Knecht S, Cohen LG. Dopaminergic influences on formation of a motor memory. Ann Neurol. 2005 Jul;58(1):121-30. doi: 10.1002/ana.20536.
- Results publication: PubMed 18760148Rosser N, Heuschmann P, Wersching H, Breitenstein C, Knecht S, Floel A. Levodopa improves procedural motor learning in chronic stroke patients. Arch Phys Med Rehabil. 2008 Sep;89(9):1633-41. doi: 10.1016/j.apmr.2008.02.030.
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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 Flöel, MD principal investigator
University of Münster, Department of Neurology, 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 dopamine in people with 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 9 inclusion and 2 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 21 Jan 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 was stopped early (reason given: no further funding available for recruiting and testing participants). 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?
Procedural motor learning (decrease in reaction time in ms) after the respective intervention (dopamine, transcranial direct current stimulation), compared to placebo. 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 NCT00126087, which also lists 2 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 21 Jan 2013; AzTrials last refreshed its copy on 8 Nov 2026.