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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Neuropathic Pain

Treatments: Device: BCI sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT03889353

RC17_0417

Details and patient eligibility

About

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

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

BCI sessions

Experimental group

Description:

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.

Treatment:

Device: BCI sessions