Clinical Trials Directory

Trials / Completed

CompletedNCT03889353

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
7 (actual)
Sponsor
Nantes University Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEBCI sessionsup 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.

Timeline

Start date
2019-05-09
Primary completion
2021-05-09
Completion
2021-11-09
First posted
2019-03-26
Last updated
2022-04-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03889353. Inclusion in this directory is not an endorsement.