Feasibility Study to Evaluate the Observance Rehabilitation of Upper Limbs by Visual-motor Simulation Associated at Transcranial Direct Current Stimulation (tDCS) in Hemiparetic Patient Post-stroke (SIMSTIM)

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Stroke

Treatments

Diagnostic Test: Tolerance Assessment Questionnaire

Diagnostic Test: Frenchay arm test

Diagnostic Test: Ashworth's scale

Diagnostic Test: Goal Attainment Scaling (GAS)

Diagnostic Test: Abilhand questionnaire

Diagnostic Test: Computerized Mirror Therapy (CMT)

Diagnostic Test: transcranial Direct Current Stimulation (tDCS)

Diagnostic Test: Fugl-Meyer test

Study type

Interventional

Funder types

Other

Identifiers

NCT03815266

2018-A01883-52 (Other Identifier)

1708098

Details and patient eligibility

About

Although the mirror therapy is recognized as effective, its practice is difficult, especially with hemiplegic patients. It is difficult for them to understand, control the movements and carry out a double task with the two upper limbs. The implementation of a Computerized Mirror Therapy (CMT) with the Intensive Visual Simulation 3 (IVS3) device makes it possible to limit these problems by proposing pre-recorded sessions, not limited to the right or left hemi-space, and proposing a work on proximal motricity. Since the functional prognosis of the upper hemiplegic limb remains mostly unfavourable, a wide range of interventions should be proposed. There is currently a consensus to consider the use of transcranial Direct Current Stimulation (tDCS) stimulation in functional recovery after stroke as a method to enhance the effectiveness of training techniques. Although all motor therapies can theoretically benefit from increased effectiveness by the addition of transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT) has a high potential for sensitivity to transcranial Direct Current Stimulation (tDCS) due to the intensity of the motor training of the upper limb applied.

Full description

The primary objective of this study is to investigate the feasibility of a program combining Computerized Mirror Therapy (CMT) with dual- transcranial Direct Current Stimulation (tDCS) stimulation by evaluating observance to hemiparetic stroke patients.

Enrollment

9 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with first ischemic or hemorrhagic stroke for less than one year, having not recidivated since then and responsible for initially complete left or right hemiplegia
Modified Frenchay arm test score <70 (/ 100)
Without a neurological history other than stroke
Having signed the written consent and affiliated or entitled to a social security scheme

Exclusion criteria

Patient with contraindications to transcranial Direct Current Stimulation (tDCS) or Transcranial Magnetic Stimulation (TMS) (brain metal implant, pacemaker, other implanted active medical device)
Patient who didn't have cerebral Magnetic Resonance Imaging (MRI) imaging during their stroke
With complete lesion of the primary motor cortex
With alcohol / drug dependence
With psychiatric illness, cognitive impairment, uncontrolled disease / epilepsy, malignant disease, severe renal or pulmonary disease
With a history of disabling associated disease
With cerebellar syndrome
Pregnancy

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Patient with first ischemic or hemorrhagic stroke

Experimental group

Description:

Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes). In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS).

Treatment: