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

Primary Purpose

Transcranial Direct Current Stimulation, Cerebrovascular Accident (CVA)

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • K U Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Upper limb motor function training + tDCS

upper limb motor function training + sham tDCS

Arm Description

Bi-hemispheric tDCS with motor function training

sham tDCS with motor function training

Outcomes

Primary Outcome Measures

Change of Fugl-Meyer assessment (FMA) score

Secondary Outcome Measures

Change of Modified Ashworth scale (MAS)

Full Information

First Posted
July 24, 2014
Last Updated
March 27, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02210403
Brief Title
The Influence of tDCS on the Arm and Hand Function in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 18, 2013 (undefined)
Primary Completion Date
September 28, 2014 (Actual)
Study Completion Date
September 28, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Direct Current Stimulation, Cerebrovascular Accident (CVA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upper limb motor function training + tDCS
Arm Type
Active Comparator
Arm Description
Bi-hemispheric tDCS with motor function training
Arm Title
upper limb motor function training + sham tDCS
Arm Type
Sham Comparator
Arm Description
sham tDCS with motor function training
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
K U Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
33175411
Citation
Elsner 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.
Results Reference
derived

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

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