The Effect of Methylphenidate on Motor Learning in Stroke Patients

March 26, 2008 updated by: University of Aarhus

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Neurology
      • Hammel, Denmark, 8450
        • Hammel Neurocenter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Training induced changes in Short interval Intracortical Inhibition (SICI).
Training induced changes in Intracortical facilitation (ICF)

Secondary Outcome Measures

Outcome Measure
Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Jakob U Blicher, MD, Hammel neurocenter Aarhus University Hospital Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

November 3, 2006

First Submitted That Met QC Criteria

November 3, 2006

First Posted (Estimate)

November 6, 2006

Study Record Updates

Last Update Posted (Estimate)

March 27, 2008

Last Update Submitted That Met QC Criteria

March 26, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-002554-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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