StrokeSIMSTIMNCT03815266
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
A study testing transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT) and Tolerance Assessment Questionnaire in people with Stroke, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT) and Tolerance Assessment Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2018to 14 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT), Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test
- Keywords
- transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT), hemiparetic, Ischemic, stroke, Intensive Visual Simulation3 (IVS3)
- Medical subject headings
- Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current Stimulation (tDCS)Diagnostic test
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).
Computerized Mirror Therapy (CMT)Diagnostic test
Also called Intensive Visual Simulation3 (IVS3)
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).
Tolerance Assessment QuestionnaireDiagnostic test
The Tolerance Assessment Questionnaire will be completed at the end of each session.
Ashworth's scaleDiagnostic test
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.
Frenchay arm testDiagnostic 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.
Abilhand questionnaireDiagnostic test
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.
Fugl-Meyer testDiagnostic 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.
Goal Attainment Scaling (GAS)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient with first ischemic or hemorrhagic stroke | Experimental | 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). Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 40
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 40
Tolerance Assessment Questionnaire
Analysis the results of the Tolerance Assessment Questionnaire.
Measured: 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.
Measured: Day 40
Evaluation of the program by Goal Attainment Scaling (GAS)
Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results.
Measured: 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.
Measured: 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.
Measured: Day 70
Abilities to perform several activities - Abilhand questionnaire
Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.
Measured: Day 40
Abilities to perform several activities - Abilhand questionnaire
Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results.
Measured: Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start20 Sep 2018
- Primary completion7 Mar 2022
- Study completion14 Apr 2022
Why it stopped: The study was stopped due to lack of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal GIRAUX, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815266
- Sponsor's protocol ID
- 1708098
- Other IDs
- 2018-A01883-52
- Acronym
- SIMSTIM
- Status last verified
- Apr 2023
- First submitted
- 6 Nov 2018
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03815266
- Acronym / sponsor ID
- SIMSTIM / 1708098
- Conditions
- Stroke
- Keywords
- transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT), hemiparetic, Ischemic, stroke, Intensive Visual Simulation3 (IVS3)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to lack of inclusions
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with first ischemic or hemorrhagic stroke | Experimental | 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)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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Patient with first ischemic or hemorrhagic stroke |
| Computerized Mirror Therapy (CMT)Also: Intensive Visual Simulation3 (IVS3)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). | Diagnostic test | Patient with first ischemic or hemorrhagic stroke |
| Tolerance Assessment QuestionnaireThe Tolerance Assessment Questionnaire will be completed at the end of each session. | Diagnostic test | Patient with first ischemic or hemorrhagic stroke |
| Ashworth's scaleAshworth'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 | Patient with first ischemic or hemorrhagic stroke |
| Frenchay arm testFrenchay 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 | Patient with first ischemic or hemorrhagic stroke |
| Abilhand questionnaireAbilhand 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 | Patient with first ischemic or hemorrhagic stroke |
| Fugl-Meyer testFugl-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 | Patient with first ischemic or hemorrhagic stroke |
| 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. | Diagnostic test | Patient with first ischemic or hemorrhagic stroke |
Primary outcome
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.
11 secondary outcomes
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
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
occurrence of epileptic seizure
Time frame: Day 40
occurrence of Anxiety crisis
Time frame: Day 40
Tolerance Assessment Questionnaire
Time frame: Up to day 70
Evaluation of the program by Goal Attainment Scaling (GAS)
Time frame: Day 40
Evaluation of the program by Goal Attainment Scaling (GAS)
Time frame: Day 70
Quantitative improvement of the deficiencies - Fugl-Meyer test
Time frame: Day 40
Quantitative improvement of the deficiencies - Fugl-Meyer test
Time frame: Day 70
Abilities to perform several activities - Abilhand questionnaire
Time frame: Day 40
Abilities to perform several activities - Abilhand questionnaire
Time frame: Day 70
Results and safety
The study was stopped early (reason given: The study was stopped due to lack of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal GIRAUX, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT) and Tolerance Assessment Questionnaire in people with Stroke, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to lack of inclusions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of observance of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) (time frame: Up to Day 40). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.