NCT02210403CompletedNot Applicable
The Influence of tDCS on the Arm and Hand Function in Stroke Patients
Universitaire Ziekenhuizen KU Leuven1 site in 1 country26 target enrollmentStarted: April 18, 2013Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Change of Fugl-Meyer assessment (FMA) score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Family history of Epilepsy
Arms & Interventions
Upper limb motor function training + tDCS
Active Comparator
Bi-hemispheric tDCS with motor function training
Intervention: transcranial direct current stimulation (tDCS) (Device)
upper limb motor function training + sham tDCS
Sham Comparator
sham tDCS with motor function training
Intervention: transcranial direct current stimulation (tDCS) (Device)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Study Sites (1)
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