The Effect of Methylphenidate on Motor Learning in Stroke Patients
Primary Purpose
Cerebrovascular Accident
Status
Terminated
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Methylphenidate
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident
Eligibility 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
Sites / Locations
- Department of neurology
- Hammel neurocenter
Outcomes
Primary Outcome Measures
Training induced changes in Short interval Intracortical Inhibition (SICI).
Training induced changes in Intracortical facilitation (ICF)
Secondary Outcome Measures
Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00396058
Brief Title
The Effect of Methylphenidate on Motor Learning in Stroke Patients
Official Title
Methylphenidats Betydning for motoriskindlæring Hos Patienter Med Apopleksi
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
Recruitment of patients proved much too difficult based on the chosen criteria.
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
13 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Primary Outcome Measure Information:
Title
Training induced changes in Short interval Intracortical Inhibition (SICI).
Title
Training induced changes in Intracortical facilitation (ICF)
Secondary Outcome Measure Information:
Title
Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob U Blicher, MD
Organizational Affiliation
Hammel neurocenter Aarhus University Hospital Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of neurology
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Hammel neurocenter
City
Hammel
ZIP/Postal Code
8450
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Effect of Methylphenidate on Motor Learning in Stroke Patients
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