Clinical trial NCT03889353: Brain Computer Interface and Virtual Reality (BCI-VR) for Pain Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
First posted: 2019-03-26
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of BCI intervention on mean daily pain
timeFrame: month 6
Secondary outcomes:
measure: Evaluate the effectiveness of the BCI intervention on paroxysmal pains
timeFrame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6
measure: Evaluate the effectiveness of the BCI intervention on paroxysmal pains
timeFrame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6
measure: Evaluate the effectiveness of the BCI intervention on paroxysmal pains
timeFrame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6
measure: Evaluate the effect of the intervention on quality of life: SF36
timeFrame: Day 1, 12, 90, 180
measure: Evaluate the effect of the intervention on anxiety and depression
timeFrame: Day 1, 12, 90, 180
measure: evaluating cortical plasticity
timeFrame: Day 1, 12, 30
measure: evaluating cortical plasticity
timeFrame: Day 1, 12, 30
measure: Evaluate the performance of subjects to control the neurofeedback system
timeFrame: Day 1, 12, 30
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes Uh
Study officials:
References: