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

Not Applicable

Completed

• Conditions: Transcranial Direct Current Stimulation; Cerebrovascular Accident (CVA)
• Interventions: Device: transcranial direct current stimulation (tDCS)

• Registration Number: NCT02210403
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-02
• Study Start: 2013-04-18
• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-06
• Primary Completion: 2014-09-28
• Study Completion: 2014-09-28
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Upper limb motor function training + tDCS	transcranial direct current stimulation (tDCS)	Bi-hemispheric tDCS with motor function training
upper limb motor function training + sham tDCS	transcranial direct current stimulation (tDCS)	sham tDCS with motor function training

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

K U Leuven; 🇧🇪 Leuven, Belgium