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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)

Primary Purpose

Stroke

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation (tDCS)
Computerized Mirror Therapy (CMT)
Tolerance Assessment Questionnaire
Ashworth's scale
Frenchay arm test
Abilhand questionnaire
Fugl-Meyer test
Goal Attainment Scaling (GAS)
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT), hemiparetic, Ischemic, stroke, Intensive Visual Simulation3 (IVS3)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chu Saint-Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with first ischemic or hemorrhagic stroke

Arm 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Tolerance Assessment Questionnaire
Analysis the results of the Tolerance Assessment Questionnaire.
Evaluation of the program by Goal Attainment Scaling (GAS)
Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.
Evaluation of the program by Goal Attainment Scaling (GAS)
Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.
Quantitative improvement of the deficiencies - Fugl-Meyer test
Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.
Quantitative improvement of the deficiencies - Fugl-Meyer test
Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.
Abilities to perform several activities - Abilhand questionnaire
Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.
Abilities to perform several activities - Abilhand questionnaire
Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.

Full Information

First Posted
November 6, 2018
Last Updated
April 25, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03815266
Brief 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
Acronym
SIMSTIM
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to lack of inclusions
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
March 7, 2022 (Actual)
Study Completion Date
April 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT), hemiparetic, Ischemic, stroke, Intensive Visual Simulation3 (IVS3)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient with first ischemic or hemorrhagic stroke
Arm Type
Experimental
Arm 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).
Intervention Type
Diagnostic Test
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS)
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Computerized Mirror Therapy (CMT)
Other Intervention Name(s)
Intensive Visual Simulation3 (IVS3)
Intervention Description
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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Tolerance Assessment Questionnaire
Intervention Description
The Tolerance Assessment Questionnaire will be completed at the end of each session.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ashworth's scale
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Frenchay arm test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Abilhand questionnaire
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Fugl-Meyer test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Goal Attainment Scaling (GAS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of observance of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS)
Description
Rate of observance of the program CMT + tDCS. It is will be measured by the number of patients who will be finished the study.
Time Frame
Up to Day 40
Secondary Outcome Measure Information:
Title
Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test
Description
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.
Time Frame
Day 40
Title
Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test
Description
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.
Time Frame
Day 70
Title
occurrence of epileptic seizure
Description
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.
Time Frame
Day 40
Title
occurrence of Anxiety crisis
Description
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.
Time Frame
Day 40
Title
Tolerance Assessment Questionnaire
Description
Analysis the results of the Tolerance Assessment Questionnaire.
Time Frame
Up to day 70
Title
Evaluation of the program by Goal Attainment Scaling (GAS)
Description
Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.
Time Frame
Day 40
Title
Evaluation of the program by Goal Attainment Scaling (GAS)
Description
Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.
Time Frame
Day 70
Title
Quantitative improvement of the deficiencies - Fugl-Meyer test
Description
Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.
Time Frame
Day 40
Title
Quantitative improvement of the deficiencies - Fugl-Meyer test
Description
Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results.
Time Frame
Day 70
Title
Abilities to perform several activities - Abilhand questionnaire
Description
Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.
Time Frame
Day 40
Title
Abilities to perform several activities - Abilhand questionnaire
Description
Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.
Time Frame
Day 70

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal GIRAUX, PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint-Étienne
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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