Back to resultsBrain Computer Interface and Virtual Reality (BCI-VR) for Pain Treatment (GHOST)
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
BCI sessions
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
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
Sites / Locations
- Nantes Uh
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BCI sessions
Arm 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.
Outcomes
Primary Outcome Measures
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%
Secondary Outcome Measures
Evaluate the effectiveness of the BCI intervention on paroxysmal pains
duration of the paroxysmal pains
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
Evaluate the effectiveness of the BCI intervention on paroxysmal pains
the frequency of paroxysmal pains
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).
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.
evaluating cortical plasticity
MRI analysis the physiopathological mechanisms governing phantom pain
evaluating cortical plasticity
EEG analysis the physiopathological mechanisms governing phantom pain
Evaluate the performance of subjects to control the neurofeedback system
Motor Imagery Questionnaire
Full Information
NCT ID
NCT03889353
First Posted
March 8, 2019
Last Updated
April 20, 2022
Sponsor
Nantes University Hospital
Collaborators
Fondation Apicil
1. Study Identification
Unique Protocol Identification Number
NCT03889353
Brief Title
Brain Computer Interface and Virtual Reality (BCI-VR) for Pain Treatment
Acronym
GHOST
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
May 9, 2021 (Actual)
Study Completion Date
November 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Fondation Apicil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BCI sessions
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
BCI sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of BCI intervention on mean daily pain
Description
Determination by curve fitting technique (regression analysis) of the peak effect and calculation of the rate of improvement: success if> 30%
Time Frame
month 6
Secondary Outcome Measure Information:
Title
Evaluate the effectiveness of the BCI intervention on paroxysmal pains
Description
duration of the paroxysmal pains
Time Frame
60 days from day -30 to day + 30 , once a week from Month 1 to month 6
Title
Evaluate the effectiveness of the BCI intervention on paroxysmal pains
Description
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
Time Frame
60 days from day -30 to day + 30 , once a week from Month 1 to month 6
Title
Evaluate the effectiveness of the BCI intervention on paroxysmal pains
Description
the frequency of paroxysmal pains
Time Frame
60 days from day -30 to day + 30 , once a week from Month 1 to month 6
Title
Evaluate the effect of the intervention on quality of life: SF36
Description
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).
Time Frame
Day 1, 12, 90, 180
Title
Evaluate the effect of the intervention on anxiety and depression
Description
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.
Time Frame
Day 1, 12, 90, 180
Title
evaluating cortical plasticity
Description
MRI analysis the physiopathological mechanisms governing phantom pain
Time Frame
Day 1, 12, 30
Title
evaluating cortical plasticity
Description
EEG analysis the physiopathological mechanisms governing phantom pain
Time Frame
Day 1, 12, 30
Title
Evaluate the performance of subjects to control the neurofeedback system
Description
Motor Imagery Questionnaire
Time Frame
Day 1, 12, 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Nantes Uh
City
Nantes
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brain Computer Interface and Virtual Reality (BCI-VR) for Pain Treatment
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