Neuropathic Pain
Conditions
Brief summary
Pilot Interventional study with minimal risks and constraints, prospective, monocentric. Safety and Efficacity evaluation of a Novel Medical Device.
Detailed description
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.
Interventions
DEVICEBCI sessions
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.
Sponsors
Fondation Apicil
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of BCI intervention on mean daily pain | month 6 | Determination by curve fitting technique (regression analysis) of the peak effect and calculation of the rate of improvement: success if\> 30% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of the BCI intervention on paroxysmal pains | 60 days from day -30 to day + 30 , once a week from Month 1 to month 6 | duration of the paroxysmal pains |
| Evaluate the effect of the intervention on quality of life: SF36 | Day 1, 12, 90, 180 | 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). |
| Evaluate the effect of the intervention on anxiety and depression | Day 1, 12, 90, 180 | 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. |
| evaluating cortical plasticity | Day 1, 12, 30 | MRI analysis the physiopathological mechanisms governing phantom pain |
| Evaluate the performance of subjects to control the neurofeedback system | Day 1, 12, 30 | Motor Imagery Questionnaire |
Countries
France
Outcome results
None listed