Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation

August 23, 2018 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used in chronic stroke patients to improve a variety of functions with upper limb.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

tDCS and RAT will be used in chronic stroke patients to improve a variety of functions such as motor functions with upper limb.

tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. A session of RAT will be associated with tDCS/placebo. Behavioural data will be collected before and after tDCS, associated with RAT.

Study Type

Interventional

Enrollment (Actual)

21

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
      • Brussel, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Mont Godinne, Belgium
        • CHU Dinant-Godinne UCL

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • stroke with at least slight deficit in upper limb

Exclusion Criteria:

  • epilepsy
  • contraindication to tDCS
  • presence of metal in the head
  • inability to understand/complete behavioural tasks
  • chronic intake of alcohol or recreative drugs
  • major health condition (e.g. terminal renal failure, instable heart failure etc …)
  • pregnancy

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Real stimulation
real tDCS associated with robot-assisted therapy (RAT)
Device: tDCS (ELDITH) and RAT (REAplan)
Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan
Sham Comparator: Sham stimulation
Sham tDCS associated with RAT
Device: tDCS (ELDITH) and RAT (REAplan)
Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Upper Limb Kinematics
Time Frame: kinematic assessment of the upper limb at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
kinematic assessment of the upper limb at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)

Secondary Outcome Measures

Outcome Measure
Time Frame
Box and Block test
Time Frame: Manual dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Manual dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Purdue Pegboard Test
Time Frame: Digital dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
Digital dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)

Collaborators and Investigators

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

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

University Hospital of Mont-Godinne

Investigators

  • Principal Investigator: Thierry Lejeune, Professor, Cliniques universitaires Saint-Luc

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

January 9, 2014

Primary Completion (Actual)

January 9, 2014

Study Completion (Actual)

July 30, 2015

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 30, 2015

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • IONS-Gilliaux-03

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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