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NCT02210403 Clinical Trial

The Influence of tDCS on the Arm and Hand Function in Stroke Patients

Transcranial Direct Current Stimulation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02210403
Other study ID # S54797
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2013
Est. completion date September 28, 2014

Study information
Verified date February 2013
Source Universitaire Ziekenhuizen KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether tDCS in combination with motor training can improve hand and arm function in stroke patients.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date September 28, 2014
Est. primary completion date September 28, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Stroke patients onset > 6 months - First ever stroke - Decreased hand and arm function - Mini Mental State Examination (>24) Exclusion Criteria: - Depression - Pregnancy - Alcohol abuse - Aneurysm clips - Pacemaker - Neurostimulator - Implemented defibrillator - Magnetically activated implant or device - implemented pump - Spinal cord simulator - Implemented hearing aid - Artificial or prosthetic limb - Metal parts in the body - Any external or internal metal - Artificial heart valve - Other implants - History of brain surgery - Migraine - Family history of Epilepsy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• transcranial direct current stimulation (tDCS)

Locations
Country Name City State
Belgium K U Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Other Change of motor task performance Change from baseline motor task performance on the 3rd intervention day, and change from baseline in motor task performance at 1 week post intervention
Primary Change of Fugl-Meyer assessment (FMA) score Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention
Secondary Change of Modified Ashworth scale (MAS) Change from baseline in MAS scale on the 3rd intervention day; change from baseline in MAS scale at 1 week post intervention
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