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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A00230- 47 | Registry Identifier | IDRCB |
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Cerebrovascular accidents (strokes) are a major public health issue. Stroke is the 3rd leading cause of death and the leading cause of disability and loss of autonomy. In France, there are currently 130,000 new cases per year, and the aging of the population will lead to an increase in this number over the next few years. Among post-stroke impairments, motor deficit of the upper limb is the most common disability, affecting 73-88% of first-time stroke patients and 55-75% of chronic patients. Associated deficits can complicate rehabilitation management and affect recovery. The clinical profile of patients with motor deficits is therefore varied and complex, requiring an individualized approach. At present, only physiotherapy is recommended, with modest results.
Repeated transcranial magnetic stimulation is a therapy that can improve motor recovery, but currently has a low level of evidence according to the HAS (French Hight Health Authority), notably because of variability in efficacy due to heterogeneity in the clinical profile of patients. Nevertheless, it is still recommended for the recovery of cognitive functions, but also for resistant depression, and could be used to stimulate motor imagery (MI). MI training also has the advantage of stimulating the motor network. Difficult to achieve for a number of patients, the use of rTMS could facilitate this cognitive task and, in particular, provide better access to brain-computer interfaces (BCI). Indeed, among the innovative rehabilitation therapies, BCIs have emerged as the most promising. By translating brain activity during a cognitive task into a command such as electrical muscle stimulation, BCIs would restore the damaged motor network and induce motor recovery. The main obstacle to their widespread use in clinical practice is their lack of reliability, as almost 30% of patients are unable to control them correctly, either because of difficulty in performing the MI task, or because of difficulty in identifying a universal brain signature.
The BCINET project aims to improve the reliability of BCIs in two ways: by improving detection of the motor imagination task using new brain signatures, and through cognitive facilitation using rTMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS-free group | No Intervention | Chronic stroke patients with motor deficit of upper limb | |
| Contralesional Inhibitory stimulation of the M1 cortex. | Experimental | The probe will be placed on the healthy motor cortex at the Extensor Carpi Radialis " hotspot " level. Performed on 15 participants (5 participants per group)
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| Ipsilesional excitatory stimulation of the M1 cortex. | Experimental | The probe will be placed on the injured motor cortex at the Extensor Carpi Radialis " hotspot " level. Performed on 15 participants (5 participants per group)
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| Personalized exitatory stimulation according to structural connectivity. | Experimental | The probe will be placed at the stimulation site identified by control theory. Performed on 15 participants (5 participants per group)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS) | Device | The repeated stimulations will be carried out using an eight-part probe detected by the infrared camera ("eight shaped tracked coil"), connected to a Rapid 2 stimulator (Magstim Company, Whitland, UK). The stimulation will be performed manually or with robotic assistance using TMS-Robot (Axilum Robotics, SCHILTIGHEIM, France) |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring primary BCI performance | Accuracy was choosen, which correspond to the percentage of correct detection of mental tasks (either MI or rest) on all tasks performed during the session. | 6 weeks, 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring secondary BCI performance by using the sensitivity indicator " recall " | Sensitivity is the proportion of correct IM task detections out of all real IM tasks | Up to 20 weeks |
| Measuring secondary BCI performance by using the positive predictive value " precision " |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo BARTOLOMEO, MD, INSERM DR2 | Contact | +33 1 57 27 41 40 | paolo.bartolomeo@upmc.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut du Cerveau | Recruiting | Paris | 75013 | France |
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Randomised Mutliple Baseline SCED.
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The positive predictive value is the proportion of correct MI detections out of all tasks detected by algorithm |
| Up to 20 weeks |
| Measuring secondary BCI performance by using the Run-Wise Cross-Validation method | To reduce the the intersessional variabilityy in accurnc, we use the Run-Wise Cross-Validation (RWCV CA) method will be used. | Up to 20 weeks |
| Assessment of the motor function using the Fugl-Meyer upper limb motor subscale (UE-FMA) | Rough assessment of dexterity during goal directed movements | Inclusion visit, 6 weeks |
| Assessment of the motor function using Box and Block Test (BBT) | Rough assessment of dexterity during goal directed movements | Up to 20 weeks |
| Assessment of the motor function using the Grip and Pinch force | Pure evaluation of the finger flexion force using dynamometer | Up to 20 weeks |
| Evaluation of spasticity | Will be assessed and monitored using the modified Ashworth scale (mAs score) | Inclusion visit, 6 weeks |
| Hemineglet assessment by text reading test | A text reading test in which the number of words correctly read in one minute and the percentage of words omitted will be counted | Up to 20 weeks |
| Hemineglet assessment by line bissection test | The measurement of the center deviation will be quantified | Up to 20 weeks |
| Analysis of spectral power | Measurement of the power of electrical signal produced by the brain depending on frequency | Up to 20 weeks |
| Phase-Amplitude Coupling (PAC) analysis | By analysing the phase-amplitude relationships of different frequency bands in the EEG signal | Up to 20 weeks |
| Quantification of the functional connectivity (FC) | To quantify this communication, we will use a correlation matrix constructed by calculating the coefficients of spectral coherence between all of EEG channels pairs | 2 minutes before starting rTMS stimulation |
| Measurement of cortical excitability (Motor Evoked Potentials) | Assessment of the amplitude of MEPs per single shock TMS and representes the therapeutic target of rTMS | Inclusion visit, 6 weeks, 18 weeks |
| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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