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

Nantes University Hospital7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuropathic Pain

Interventions

BCI sessionsDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Nantes Uh

Nantes, France

Outcomes

Primary Outcomes

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%

Time frame: month 6

Secondary Outcomes

Evaluate the effectiveness of the BCI intervention on paroxysmal pains

duration of the paroxysmal pains

Time frame: 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

Time frame: 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

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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