Clinical trial NCT03815266: 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
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: transcranial Direct Current Stimulation (tDCS)
Computerized Mirror Therapy (CMT)
hemiparetic
Ischemic
stroke
Intensive Visual Simulation3 (IVS3)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of observance of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS)
timeFrame: Up to Day 40
Secondary outcomes:
measure: Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test
timeFrame: Day 40
measure: Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test
timeFrame: Day 70
measure: occurrence of epileptic seizure
timeFrame: Day 40
measure: occurrence of Anxiety crisis
timeFrame: Day 40
measure: Tolerance Assessment Questionnaire
timeFrame: Up to day 70
measure: Evaluation of the program by Goal Attainment Scaling (GAS)
timeFrame: Day 40
measure: Evaluation of the program by Goal Attainment Scaling (GAS)
timeFrame: Day 70
measure: Quantitative improvement of the deficiencies - Fugl-Meyer test
timeFrame: Day 40
measure: Quantitative improvement of the deficiencies - Fugl-Meyer test
timeFrame: Day 70
measure: Abilities to perform several activities - Abilhand questionnaire
timeFrame: Day 40
measure: Abilities to perform several activities - Abilhand questionnaire
timeFrame: Day 70
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pascal GIRAUX, PhD
role: PRINCIPAL_INVESTIGATOR
References: