The Effect of Methylphenidate on Motor Learning in Stroke... | NCT00396058

Studies
The Effect of Methylphenidate on Motor Learning in Stroke Patients

NCT00396058

Sponsor

University of Aarhus

Status

Terminated

Last Update Posted

Mar 27, 2008Estimated

Enrollment

13Estimated

Phase

Phase 4

Conditions

Cerebrovascular Accident

Interventions

Methylphenidate

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment of patients proved much too difficult based on the chosen criteria.

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Not provided

Completion Date

Mar 2008Actual

First Submitted Date

Nov 3, 2006

First Submission Date that Met QC Criteria

Nov 3, 2006

First Posted Date

Nov 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2008

Last Update Posted Date

Mar 27, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Estimated

Name	Type	Description	Arm Group Labels	Other Names
Methylphenidate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Training induced changes in Short interval Intracortical Inhibition (SICI).
Training induced changes in Intracortical facilitation (ICF)

Secondary Outcomes

Measure	Description	Time Frame
Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jakob U Blicher, MD	Hammel neurocenter Aarhus University Hospital Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of neurology		Aarhus	Aarhus	8000	Denmark
Hammel neurocenter

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008774	Methylphenidate

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided