The Effect of Methylphenidate on Motor Learning in Stroke Patients

Cerebrovascular Accident Clinical Trial

Official title:

Methylphenidats Betydning for motoriskindlæring Hos Patienter Med Apopleksi

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00396058
• Other study ID #: 2006-002554-29
• Status: Terminated
• Phase: Phase 4
• First received: November 3, 2006
• Last updated: March 26, 2008
• Start date: November 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Drug:
• Methylphenidate

Locations

Country	Name	City	State
Denmark	Department of neurology	Aarhus
Denmark	Hammel neurocenter	Hammel

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Training induced changes in Short interval Intracortical Inhibition (SICI).
Primary	Training induced changes in Intracortical facilitation (ICF)
Secondary	Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo