Impact of tDCS on Locomotion and Equilibrium in Hemiplegic Patients "HEMILOCOSTICOR"

Active, not recruiting

Phase 4 Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Anodal tDCS and sham tDCS stimulations Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: sham and then anodal
    Description: visit 2 sham stimulation (120 seconds) and visit 3 anodal stimulation (30 minutes)
    ARM 2: Kind: Experimental
    Label: anodal and then sham
    Description: visit 2 anodal stimulation (30 minutes) and visit 3 sham stimulation (120 seconds)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Quantify of variability of the center-of-mass movement 30 minuts No
Secondary Symmetry index calculating 30 Minutes No
Secondary Continuous relative phase 30 Minutes No
Secondary Functional data 30 minutes No

Sponsors