The Influence of tDCS on the Arm and Hand Function in Stroke Patients
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
1 active site
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
April 18, 2013
CompletedFirst Submitted
Initial submission to the registry
July 24, 2014
CompletedFirst Posted
Study publicly available on registry
August 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2014
CompletedMarch 28, 2023
February 1, 2013
1.4 years
July 24, 2014
March 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Other Outcomes (1)
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
Study Arms (2)
Upper limb motor function training + tDCS
ACTIVE COMPARATORBi-hemispheric tDCS with motor function training
upper limb motor function training + sham tDCS
SHAM COMPARATORsham tDCS with motor function training
Interventions
Eligibility Criteria
You may qualify if:
- Stroke patients onset \> 6 months
- First ever stroke
- Decreased hand and arm function
- Mini Mental State Examination (\>24)
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
K U Leuven
Leuven, 3000, Belgium
Related Publications (2)
Zhang X, Meesen R, Swinnen SP, Feys H, Woolley DG, Cheng HJ, Wenderoth N. Combining muscle-computer interface guided training with bihemispheric tDCS improves upper limb function in patients with chronic stroke. J Neurophysiol. 2024 Jun 1;131(6):1286-1298. doi: 10.1152/jn.00316.2023. Epub 2024 May 8.
PMID: 38716555DERIVEDElsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PMID: 33175411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2014
First Posted
August 6, 2014
Study Start
April 18, 2013
Primary Completion
September 28, 2014
Study Completion
September 28, 2014
Last Updated
March 28, 2023
Record last verified: 2013-02