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

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

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

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Device: BCI sessions

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Nantes UH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of the BCI intervention on paroxysmal pains	duration of the paroxysmal pains	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	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	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).	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.	Day 1, 12, 90, 180
evaluating cortical plasticity	MRI analysis the physiopathological mechanisms governing phantom pain	Day 1, 12, 30
evaluating cortical plasticity	EEG analysis the physiopathological mechanisms governing phantom pain	Day 1, 12, 30
Evaluate the performance of subjects to control the neurofeedback system	Motor Imagery Questionnaire	Day 1, 12, 30

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Fondation Apicil

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): May 9, 2021
• Study Completion (Actual): November 9, 2021

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: RC17_0417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No