Cerebrovascular AccidentPhase 4NCT00396058
The Effect of Methylphenidate on Motor Learning in Stroke Patients
A Phase 4 study testing Methylphenidate in people with Cerebrovascular Accident, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The purpose of the study is to determine whether methylphenidate facilitates so called short-term plasticity as measures with transcranial magnetic stimulation, in patients with stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Methylphenidate
- How many people
- 13 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2006to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Less than two months after first stroke.
- Moderate to light hand paralysis
- Measurable MEP in the abductor pollicis brevis muscle
- Able to read and understand the written information
- Signed informed consent
Who cannot join
- Epilepsy
- Glaucoma
- Hyperthyroidism
- Cardiac arrythmia
- Known heart disease or angina.
- Metal implants
Show all 10Show fewer
- Pacemaker
- Pregnancy
- Diastolic BP>100 mmHg
- In treatment with MAO-inhibitor, SSRIs og Ritalin
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of neurology
Aarhus, Aarhus, 8000
Hammel neurocenter
Hammel, Hammel, 8450
About this study
Official title: Methylphenidats Betydning for motoriskindlæring Hos Patienter Med Apopleksi
The purpose of the study is to determine whether methylphenidate facilitates so called short-term plasticity as measures with transcranial magnetic stimulation, in patients with stroke.
Read the detailed description
Stroke patients are to be examined with transcranial magnetic stimulation (TMS) before and after a short training session. TMS will be used to demonstrate changes in cortical excitability (motor threshold) and intracortical inhibition and facilitation. The effect of methylphenidate on baseline TMS measures will be evaluated as well as the effect on training induced changes in TMS measures (by comparing baseline and posttraining measures). The patients will be trained on two separate occasions, to compare the effect of Methylphenidate to placebo.
- Conditions
- Cerebrovascular Accident
- Being tested
- Methylphenidate
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Training induced changes in Short interval Intracortical Inhibition (SICI).
Training induced changes in Intracortical facilitation (ICF)
Secondary outcomes (1)
Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startNov 2006
- Study completionMar 2008
Why it stopped: Recruitment of patients proved much too difficult based on the chosen criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Jakob U Blicher, MD, Principal investigator, Hammel neurocenter Aarhus University Hospital Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396058
- Sponsor's protocol ID
- 2006-002554-29
- Status last verified
- Mar 2008
- First submitted
- 3 Nov 2006
- Last updated
- 27 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylphenidats Betydning for motoriskindlæring Hos Patienter Med Apopleksi
- ClinicalTrials.gov ID
- NCT00396058
- Acronym / sponsor ID
- 2006-002554-29
- Conditions
- Cerebrovascular Accident
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment of patients proved much too difficult based on the chosen criteria.
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Nov 2006 (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 the study is to determine whether methylphenidate facilitates so called short-term plasticity as measures with transcranial magnetic stimulation, in patients with stroke.
Detailed description
Stroke patients are to be examined with transcranial magnetic stimulation (TMS) before and after a short training session. TMS will be used to demonstrate changes in cortical excitability (motor threshold) and intracortical inhibition and facilitation. The effect of methylphenidate on baseline TMS measures will be evaluated as well as the effect on training induced changes in TMS measures (by comparing baseline and posttraining measures). The patients will be trained on two separate occasions, to compare the effect of Methylphenidate to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Less than two months after first stroke.
- Moderate to light hand paralysis
- Measurable MEP in the abductor pollicis brevis muscle
- Able to read and understand the written information
- Signed informed consent
Key exclusion criteria (10 listed)
- Epilepsy
- Glaucoma
- Hyperthyroidism
- Cardiac arrythmia
- Known heart disease or angina.
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 |
|---|---|---|
| Methylphenidate | Drug | – |
Primary outcome
Training induced changes in Short interval Intracortical Inhibition (SICI).
Training induced changes in Intracortical facilitation (ICF)
1 secondary outcome
Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo
Results and safety
The study was stopped early (reason given: Recruitment of patients proved much too difficult based on the chosen criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2008.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Jakob U Blicher, MD principal investigator
Hammel neurocenter Aarhus University Hospital Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with Cerebrovascular Accident, run by University of Aarhus at 2 sites in Denmark.
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 10 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 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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: Recruitment of patients proved much too difficult based on the chosen criteria.). 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?
Training induced changes in Short interval Intracortical Inhibition (SICI).. 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?
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 Mar 2008.