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| Name | Class |
|---|---|
| Fondation Apicil | OTHER |
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Pilot Interventional study with minimal risks and constraints, prospective, monocentric. Safety and Efficacity evaluation of a Novel Medical Device.
Upper limb's phantom pain, due to amputation or to injury of the brachial plexus are possibly due to maladaptive CNS (central nervous system facility) plasticity and thus could be decreased by retraining the sensorimotor cortex using Mental Motor Imaging guided through a novel BCI-RV feedback system : "Ghost". The aim of this study is to evaluate safety and efficacy of this BCI pain treatment developed by our team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCI sessions | Experimental | up to 3 test sessions (Day-30) to eliminate BCI illiteracy, then 10 rehabilitation sessions of 90 minutes (Day 1-Day 5 and Day 8-Day 12) - Session content : Guided training - Control of an avatar (VR, first person view) of the affected limb by motor mental imagery decoded by a brain computer interface. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCI sessions | Device | up to 3 test sessions (D-30) to eliminate BCI illiteracy, then 10 rehabilitation sessions of 90 minutes (D1-D5 and D8-D12) - Session content : Guided training - Control of an avatar (VR, first person view) of the affected limb by motor mental imagery decoded by a brain computer interface. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of BCI intervention on mean daily pain | Determination by curve fitting technique (regression analysis) of the peak effect and calculation of the rate of improvement: success if> 30% | month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of the BCI intervention on paroxysmal pains | duration of the paroxysmal pains | 60 days from day -30 to day + 30 , once a week from Month 1 to month 6 |
| Evaluate the effectiveness of the BCI intervention on paroxysmal pains |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes Uh | Nantes | France |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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the intensity of paroxysmal pains This scale measures the intensity of paroxysmal pain. It is a self-assessment. Scores measured with Visual Analog Score.
The scale is graded from 0 (no pain) to 10 (most intense pain the patient can imagine).
The value 10 (maximum) is the worst result. There is no combination of sub-ranges to compute the score
| 60 days from day -30 to day + 30 , once a week from Month 1 to month 6 |
| Evaluate the effectiveness of the BCI intervention on paroxysmal pains | the frequency of paroxysmal pains | 60 days from day -30 to day + 30 , once a week from Month 1 to month 6 |
| Evaluate the effect of the intervention on quality of life: SF36 | SF36 Questionnaire quality of life For each question, an algorithm allows the calculation of scores to obtain a number between 0 (zero quality - worse outcome) and 100 (maximum quality). | Day 1, 12, 90, 180 |
| Evaluate the effect of the intervention on anxiety and depression | HAD questionnaire : Hospital Anxiety and Depression scale It includes 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), resulting in two scores (maximum score of each score = 21). To detect anxious and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D):
| Day 1, 12, 90, 180 |
| evaluating cortical plasticity | MRI analysis the physiopathological mechanisms governing phantom pain | Day 1, 12, 30 |
| evaluating cortical plasticity | EEG analysis the physiopathological mechanisms governing phantom pain | Day 1, 12, 30 |
| Evaluate the performance of subjects to control the neurofeedback system | Motor Imagery Questionnaire | Day 1, 12, 30 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |