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)

• ClinicalTrials.gov Identifier: NCT03815266
• Recruitment Status: Recruiting
• First Posted: January 24, 2019
• Last Update Posted: August 12, 2021
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Saint Etienne

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke	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)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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.
• Actual Study Start Date: September 20, 2018
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: March 2023

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test [ Time Frame: Day 40 ]

   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.

2. Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test [ Time Frame: Day 70 ]

   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.

3. occurrence of epileptic seizure [ Time Frame: Day 40 ]
   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.
4. occurrence of Anxiety crisis [ Time Frame: Day 40 ]
   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.
5. Tolerance Assessment Questionnaire [ Time Frame: Up to day 70 ]
   Analysis the results of the Tolerance Assessment Questionnaire.
6. Evaluation of the program by Goal Attainment Scaling (GAS) [ Time Frame: Day 40 ]
   Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.
7. Evaluation of the program by Goal Attainment Scaling (GAS) [ Time Frame: Day 70 ]
   Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.
8. Quantitative improvement of the deficiencies - Fugl-Meyer test [ Time Frame: Day 40 ]
   Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.
9. Quantitative improvement of the deficiencies - Fugl-Meyer test [ Time Frame: Day 70 ]
   Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.
10. Abilities to perform several activities - Abilhand questionnaire [ Time Frame: Day 40 ]
    Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.
11. Abilities to perform several activities - Abilhand questionnaire [ Time Frame: Day 70 ]
    Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Pascal GIRAUX, PhD; (0)477127756 ext +33; pascal.giraux@chu-st-etienne.fr

Contact: Florence RANCON, CRA; (0)477829458 ext +33; florence.rancon@chu-st-etienne.fr

Locations

France

Chu Saint-Etienne; Recruiting

Saint-Étienne, France

Principal Investigator: Pascal GIRAUX, PhD

Sub-Investigator: Agnès CONDEMINE, MD

Sub-Investigator: Bérénice ZAGORDA, MD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Pascal GIRAUX, PhD; CHU SAINT-ETIENNE

More Information

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT03815266
• Other Study ID Numbers: 1708098; 2018-A01883-52 ( Other Identifier: ANSM )
• First Posted: January 24, 2019
• Last Update Posted: August 12, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

transcranial Direct Current Stimulation (tDCS); Computerized Mirror Therapy (CMT); hemiparetic; Ischemic; stroke; Intensive Visual Simulation3 (IVS3)

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases