Brain Computer Interface and Virtual Reality (BCI-VR) for Pain Treatment

Study Overview
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Brief Summary
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Pilot Interventional study with minimal risks and constraints, prospective, monocentric. Safety and Efficacity evaluation of a Novel Medical Device.

Detailed Description
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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.

Official Title
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Is Mental Motor Imagery Training Using GHOST, a Novel BCI-VR Feedback System (Brain Computer Interface and Virtual Reality) Efficient and Safe for Pain Relief in Phantom Limb Pain After Upper Limb Amputation or Brachial Plexus Lesion

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Device: BCI sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neuropathic pain / Phantom limb pain Mean pain score >3 centimeter Permanent pain If Plexus Brachial injury : > 6 month If Amputation : at least at wrist level Motor and Sensory deficit : complete or incomplete Informed consent Public Health Insurance Exclusion Criteria: MRI contraindication Subject included in another interventional study Pregnant women Majors under guardianship or curatorship or safeguard of justice History of associated head injury or any other neurological pathology altering the sensorimotor cerebral system or cognitive abilities and higher functions. Presence of other lesions of the peripheral nervous system that may induce associated neuropathic pain. Head trauma associated altering somatosensory system or cognitive abilities and higher functions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCI sessions<br>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. | Device: BCI sessions<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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): 7 or less: lack of symptomatology 8 to 10: doubtful symptomatology - 11 and more: definite symptomatology. | 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 |