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

Neuropathic Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889353
• Other study ID #: RC17_0417
• Status: Completed
• Phase: N/A
• Start date: May 9, 2019
• Est. completion date: November 9, 2021

Study information

• Verified date: April 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 9, 2021
• Est. primary completion date: May 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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.

Locations

Country	Name	City	State
France	Nantes Uh	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Fondation Apicil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	evaluating cortical plasticity	MRI analysis the physiopathological mechanisms governing phantom pain	Day 1, 12, 30
Secondary	evaluating cortical plasticity	EEG analysis the physiopathological mechanisms governing phantom pain	Day 1, 12, 30
Secondary	Evaluate the performance of subjects to control the neurofeedback system	Motor Imagery Questionnaire	Day 1, 12, 30