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The Effect of Methylphenidate on Motor Learning in Stroke Patients

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ClinicalTrials.gov Identifier: NCT00396058
Recruitment Status : Terminated (Recruitment of patients proved much too difficult based on the chosen criteria.)
First Posted : November 6, 2006
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Drug: Methylphenidate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Methylphenidats Betydning for motoriskindlæring Hos Patienter Med Apopleksi
Study Start Date : November 2006
Actual Study Completion Date : March 2008

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Primary Outcome Measures :
  1. Training induced changes in Short interval Intracortical Inhibition (SICI).
  2. Training induced changes in Intracortical facilitation (ICF)

Secondary Outcome Measures :
  1. Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Epilepsy
  • Glaucoma
  • Hyperthyroidism
  • Cardiac arrythmia
  • Known heart disease or angina.
  • Metal implants
  • Pacemaker
  • Pregnancy
  • Diastolic BP>100 mmHg
  • In treatment with MAO-inhibitor, SSRIs og Ritalin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396058


Locations
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Denmark
Department of neurology
Aarhus, Denmark, 8000
Hammel neurocenter
Hammel, Denmark, 8450
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Jakob U Blicher, MD Hammel neurocenter Aarhus University Hospital Denmark
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ClinicalTrials.gov Identifier: NCT00396058    
Other Study ID Numbers: 2006-002554-29
First Posted: November 6, 2006    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents