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

NCT ID: NCT03889353

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-09
• Study Completion Date: 2021-11-09

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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BCI sessions

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.

Group Type: EXPERIMENTAL

BCI sessions

Intervention Type: DEVICE

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.

Interventions

BCI 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Apicil

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nantes Uh

Nantes, , France

Countries

France

Other Identifiers

RC17_0417

Identifier Type: -

Identifier Source: org_study_id