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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02210403
Recruitment Status : Unknown
Verified February 2013 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : August 6, 2014
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Transcranial Direct Current Stimulation Cerebrovascular Accident (CVA) Device: transcranial direct current stimulation (tDCS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2013
Estimated Primary Completion Date : September 2015
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Upper limb motor function training + tDCS
Bi-hemispheric tDCS with motor function training
 Device: transcranial direct current stimulation (tDCS)
Sham Comparator: upper limb motor function training + sham tDCS
sham tDCS with motor function training
 Device: transcranial direct current stimulation (tDCS)


Outcome Measures
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Primary Outcome Measures :
  1. Change of Fugl-Meyer assessment (FMA) score [ Time Frame: Change from baseline in FMA score on the 3rd intervention day; change from baseline in FMA score at 1 week post intervention ]

Secondary Outcome Measures :
  1. Change of Modified Ashworth scale (MAS) [ Time Frame: Change from baseline in MAS scale on the 3rd intervention day; change from baseline in MAS scale at 1 week post intervention ]

Other Outcome Measures:
  1. Change of motor task performance [ Time Frame: Change from baseline motor task performance on the 3rd intervention day, and change from baseline in motor task performance at 1 week post intervention ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210403


Contacts
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Contact: Xue Zhang 003216376454 xue.zhang@faber.kuleuven.be

Locations
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Belgium
K U Leuven Recruiting
Leuven, Belgium, 3000
Contact: Xue Zhang    +3216376454    xue.zhang@faber.kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02210403    
Other Study ID Numbers: S54797
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: February 2013
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases