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)

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.

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.

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Diagnostic test: transcranial Direct Current Stimulation (tDCS); Diagnostic test: Computerized Mirror Therapy (CMT); Diagnostic test: Tolerance Assessment Questionnaire; Diagnostic test: Ashworth's scale; Diagnostic test: Frenchay arm test; Diagnostic test: Abilhand questionnaire; Diagnostic test: Fugl-Meyer test; Diagnostic test: Goal Attainment Scaling (GAS)

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patient with first ischemic or hemorrhagic stroke; 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).

Diagnostic test: transcranial Direct Current Stimulation (tDCS); transcranial Direct Current Stimulation (tDCS) is device which consist in setting up an electrode on the skull of the patient to deliver the low intensity current. Patient will have transcranial Direct Current Stimulation (tDCS) at each session and at the same time of Computerized Mirror Therapy (CMT).; Diagnostic test: Computerized Mirror Therapy (CMT); Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3). Patient will have Computerized Mirror Therapy (CMT) at each session and at the same time of transcranial Direct Current Stimulation (tDCS).; Other Names: Intensive Visual Simulation3 (IVS3); Diagnostic test: Tolerance Assessment Questionnaire; The Tolerance Assessment Questionnaire will be completed at the end of each session.; Diagnostic test: Ashworth's scale; Ashworth's scale evaluates the resistance to stretching. This test will be completed before the start of the program, at the end of the program and one month after.; Diagnostic test: Frenchay arm test; Frenchay arm test evaluates your abilities with the affected hand to perform several actions. This test will be completed before the start of the program, at the end of the program and one month after.; Diagnostic test: Abilhand questionnaire; Abilhand questionnaire evaluates your abilities to perform several activities in the daily life with your arm affected. This test will be completed before the start of the program, at the end of the program and one month after.; Diagnostic test: Fugl-Meyer test; Fugl-Meyer test evaluates your ability to perform different movements with all the joints of your arm affected. This test will be completed before the start of the program, at the end of the program and one month after.; Diagnostic test: Goal Attainment Scaling (GAS); Goal Attainment Scaling (GAS) sets therapeutic goals with the patient before the start of the program. These goals will be checked at the end of the program and one month after.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of observance of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS)	Rate of observance of the program CMT + tDCS. It is will be measured by the number of patients who will be finished the study.	Up to Day 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test	To evaluate the effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb. It is will be measured by Frenchay arm test.	Day 40
Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test	To evaluate the effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb. It is will be measured by Frenchay arm test.	Day 70
occurrence of epileptic seizure	Measure of tolerance of the program Intensive Visual Simulation 3 (IVS3) + transcranial Direct Current Stimulation (tDCS) by the occurrence of epileptic seizure report by adverse event and serious adverse events.	Day 40
occurrence of Anxiety crisis	Measure of tolerance of the program Intensive Visual Simulation 3 (IVS3) + transcranial Direct Current Stimulation (tDCS) by the occurrence of anxiety crisis report by adverse event and serious adverse events.	Day 40
Tolerance Assessment Questionnaire	Analysis the results of the Tolerance Assessment Questionnaire.	Up to day 70
Evaluation of the program by Goal Attainment Scaling (GAS)	Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.	Day 40
Evaluation of the program by Goal Attainment Scaling (GAS)	Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.	Day 70
Quantitative improvement of the deficiencies - Fugl-Meyer test	Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.	Day 40
Quantitative improvement of the deficiencies - Fugl-Meyer test	Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.	Day 70
Abilities to perform several activities - Abilhand questionnaire	Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.	Day 40
Abilities to perform several activities - Abilhand questionnaire	Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.	Day 70

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Actual): March 7, 2022
• Study Completion (Actual): April 14, 2022

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: stroke; Ischemic; transcranial Direct Current Stimulation (tDCS); Computerized Mirror Therapy (CMT); Intensive Visual Simulation3 (IVS3); hemiparetic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 1708098; 2018-A01883-52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No