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Impact of tDCS on Locomotion and Equilibrium in Hemiplegic Patients (HEMILOCOSTICOR)

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ClinicalTrials.gov Identifier: NCT02134158
Recruitment Status : Active, not recruiting
First Posted : May 9, 2014
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The aim of this trial is to quantify the improvement of locomotion and equilibrium induced par tDCS in anode polarity position in post stroke hemiplegic patients.

Condition or disease Intervention/treatment Phase
Gait Disorders Device: anodal tDCS and sham tDCS stimulations Phase 4

Detailed Description:

This is a pilot prospective randomised crossover double blind study. 40 patients will be enrolled in two sites, with 20 patients each site.

The duration of this study is planned to be 25 months: 24 months will be for enrollment and 1 month for the follow-up.

The follow-up of patient comprises 3 visits, will be extended to 28 days for each patient:

• V1: inclusion visit:

After obtained an informed consent signed, the following analysis will be realized: a clinical assessment, quantify analysis of walking using 3D motion analysis system, assessment of equilibrium using force plate and functional abilities.

The patient will record him-self clinical scales and will respond auto-evaluation questionnaires. A cerebral magnetic resonance imaging and a blood collection of 5 ml will also be realized.

• V2-V3 (Locomotion /equilibrium assessment visit):

V2 and V3 will begin with tDCS experimental visit (EV) or tDCS placebo visit (PV), the visit order for each patient will be defined by randomization result.

During the 2 visits, the tDCS will be placed on the scalp of the patient. The anode will be placed at the hot spot of the tibialis anterior motor cortex area on the damage hemisphere, and the cathode will be placed at the controlateral orbit. The intensity of stimulation will be 2 mA.

In tDCS experimental visit, the stimulation will last 30 minutes. In tDCS placebo visit, the duration of the stimulation will only be 120 seconds, with the identical other conditions.

Before the beginning of the stimulation, a clinical assessment, a functional gait related activities evaluation and a 3D gait motion analysis associated with an evaluation of the equilibrium will be performed.

During the stimulation period, the gait and the equilibrium assessments, using 3D motion analysis will be done.

After the stimulation, the evaluations such as clinical, functional and motion analysis will be realized again.

The tDCS experimental visit and the tDCS placebo visit will be spaced one week.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Transcranial Direct Current Stimulation (tDCS) on Locomotion and Bipedal Equilibrium in Hemiplegic Patients: a Crossover Randomized Controlled Trial
Actual Study Start Date : July 2014
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: sham and then anodal
visit 2 sham stimulation (120 seconds) and visit 3 anodal stimulation (30 minutes)
Device: anodal tDCS and sham tDCS stimulations

Two conditions will be tested in randomized order: 2 arms in the first one anodal tDCS and then sham tDCS. In the other arm sham tDCS and then anodal tDCS.

All the investigations will associate with clinical, functional and 3D motion analysis assessments.


Experimental: anodal and then sham
visit 2 anodal stimulation (30 minutes) and visit 3 sham stimulation (120 seconds)
Device: anodal tDCS and sham tDCS stimulations

Two conditions will be tested in randomized order: 2 arms in the first one anodal tDCS and then sham tDCS. In the other arm sham tDCS and then anodal tDCS.

All the investigations will associate with clinical, functional and 3D motion analysis assessments.





Primary Outcome Measures :
  1. Quantify of variability of the center-of-mass movement [ Time Frame: 30 minutes ]
    Variability of the center-of-mass will be quantified during walking analysis and equilibrium assessment, for experimental and placebo visits (before, during and after stimulation) (V2 and V3) as well as in inclusion visit (V1).


Secondary Outcome Measures :
  1. Symmetry index calculating [ Time Frame: 30 Minutes ]
    Symmetry index of the spatio-temporal parameters of gait Calculating methods of the symmetry: using the robinson index

  2. Continuous relative phase [ Time Frame: 30 Minutes ]
    Assessment of the inter-segment coordination of the thigh-leg and leg-foot using the continuous relative phase.

  3. Functional data [ Time Frame: 30 minutes ]
    Time of climbing and descending 10 stairs of 11 cm Timed Up and Go test Box and Block Test



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults
  • Unilateral stroke
  • More than 6 months after stroke
  • Ability to walk during 10 minutes without stopping
  • Informed consent signed

Exclusion Criteria :

  • Patient with pacemaker
  • Claustrophobia (unable to perform a magnetic resonance imaging analysis)
  • Patient with severe aphasia or severe cognitive disorder interfering the follow-up of the trial
  • Neuro-orthopedic surgery history in the last 6 months on the studied paretic lower limb
  • Epilepsy history in the last year
  • Lack of medical insurance
  • Adult patient under the care of a guardian
  • Patient with progressive concomitant disease
  • Patient with deep brain stimulation treatment (implantation of medical device)
  • Patient with implantation of Intracranial metallic clip
  • Patient with implantation of Intracranial stent
  • Patient with implantation of ventriculoperitoneal derivation
  • Patient with implantation of intracerebral or ocular prosthetic materials
  • Patient with ferro-magnetic foreign object
  • Patient with cochlear implant
  • Patient with implantable cardioverter-defibrillator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134158


Locations
France
Raymond Poincaré Hospital
Garches, Hauts-de-Seine, France, 92380
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Nicolas ROCHE, MD, PhD Laboratory of Movement Analysis, Raymond Poincaré Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02134158     History of Changes
Other Study ID Numbers: P120135 / AOM12126
2013-A00952-43 ( Other Identifier: IDRCB )
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: October 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
tDCS, gait disorders, equilibrium, hemiplegic, stroke