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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 4

Conditions

Gait Disorders

Treatments

Device: anodal tDCS and sham tDCS stimulations

Study type

Interventional

Funder types

Other

Identifiers

NCT02134158

2013-A00952-43 (Other Identifier)

P120135 / AOM12126

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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