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

March 27, 2023 updated by: Universitaire Ziekenhuizen KU Leuven
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • K U Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Time Frame
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
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

Outcome Measure
Time Frame
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
Change from baseline motor task performance on the 3rd intervention day, and change from baseline in motor task performance at 1 week post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 18, 2013

Primary Completion (Actual)

September 28, 2014

Study Completion (Actual)

September 28, 2014

Study Registration Dates

First Submitted

July 24, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S54797

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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