Effects of tDCS on Quadriceps Strength After Stroke (tDCS(HE))

November 10, 2017 updated by: Centre d'Investigation Clinique et Technologique 805

a Controlled, Randomized Study Evaluating the Immediate Effect of One tDCS Session on Quadriceps Strength in Hemiparetic Patients.

Previous studies show that one session of tDCS allow to improve muscle strength in hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the cortical representation area of the healthy hemisphere. This approach seems to be the best relevant electrods configuration in order to restore the inter-hemispheric balance.

We hypothesis that one session of tDCS with this electrods configuration allow to improve paretic quadriceps strength in hemiparetic patients after stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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

  • France
      • Garches, France, 92380
        • Raymond Poincaré Hospital

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:

  • written consent
  • hemiparetic patient after stroke in chronic phase (> 6 months)
  • capacity to walk with or without technical assistance
  • following rehabilitation program for lower limbs

Exclusion Criteria:

  • patient with bilateral brain lesion, cerebellar syndrom, and apraxia and/or aphasia
  • previous orthopedic surgery in paretic lower limb (<6 moths)
  • usual tDCS contraindications
  • pregnant woman

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hemiplegic patient
anodal transcranial direct current stimulation
Device: transcranial Direct current stimulation
Sham Comparator: patient control
Sham transcranial direct current stimulation
Device: transcranial Direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum voluntary isometric strength of knee extensors
Time Frame: 2 hours
The maximum voluntary isometric strength of paretic knee extensors will be evaluated with a isokinetic dynamometer, which measure peak torque.
2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Resistive peak torque during passive knee flexion
Time Frame: 2h
2h
Angle related to the resistive peak torque generation of the knee extensors
Time Frame: 2h
2h
Amplitude of the interpolation twitch
Time Frame: 2h
2h
EMG activation of the knee flexors and extensors during the strength evaluations (active and passive)
Time Frame: 2h
2h
Functional evaluation of the gait performance and balance
Time Frame: 2h
2h

Collaborators and Investigators

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

Sponsor

Centre d'Investigation Clinique et Technologique 805

Collaborators

Fondation Garches

Investigators

  • Principal Investigator: Roche Nicolas, MD PH, Raymond Poincaré Hospital
  • Principal Investigator: Bensmail Djamel, MD PH, Raymond Poincaré Hospital

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 (Actual)

February 19, 2015

Primary Completion (Actual)

November 28, 2016

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00219-38

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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