NCT00396058

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 27, 2008

Status Verified

March 1, 2008

First QC Date

November 3, 2006

Last Update Submit

March 26, 2008

Conditions

Cerebrovascular Accident

Outcome Measures

Primary Outcomes (2)

  • Training induced changes in Short interval Intracortical Inhibition (SICI).

  • Training induced changes in Intracortical facilitation (ICF)

Secondary Outcomes (1)

  • Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo

Interventions

MethylphenidateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of neurology

Aarhus, Aarhus, 8000, Denmark

Location

Hammel neurocenter

Hammel, Hammel, 8450, Denmark

Location

MeSH Terms

Conditions

Stroke

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jakob U Blicher, MD

    Hammel neurocenter Aarhus University Hospital Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2006

First Posted

November 6, 2006

Study Start

November 1, 2006

Study Completion

March 1, 2008

Last Updated

March 27, 2008

Record last verified: 2008-03

Locations

DK(2)