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

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ClinicalTrials.gov Identifier: NCT03889353
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
Fondation Apicil
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE May 9, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)		 Efficacy of BCI intervention on mean daily pain [ Time Frame: month 6 ]
Determination by curve fitting technique (regression analysis) of the peak effect and calculation of the rate of improvement: success if> 30%
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2019)
  • Evaluate the effectiveness of the BCI intervention on paroxysmal pains [ Time Frame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6 ]
    duration of the paroxysmal pains
  • Evaluate the effectiveness of the BCI intervention on paroxysmal pains [ Time Frame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6 ]
    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 [ Time Frame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6 ]
    the frequency of paroxysmal pains
  • Evaluate the effect of the intervention on quality of life: SF36 [ Time Frame: Day 1, 12, 90, 180 ]
    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 [ Time Frame: Day 1, 12, 90, 180 ]
    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 [ Time Frame: Day 1, 12, 30 ]
    MRI analysis the physiopathological mechanisms governing phantom pain
  • evaluating cortical plasticity [ Time Frame: Day 1, 12, 30 ]
    EEG analysis the physiopathological mechanisms governing phantom pain
  • Evaluate the performance of subjects to control the neurofeedback system [ Time Frame: Day 1, 12, 30 ]
    Motor Imagery Questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Evaluate the effectiveness of the BCI intervention on paroxysmal pains [ Time Frame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6 ]
    duration of the paroxysmal pains
  • Evaluate the effectiveness of the BCI intervention on paroxysmal pains [ Time Frame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6 ]
    the intensity of paroxysmal pains
  • Evaluate the effectiveness of the BCI intervention on paroxysmal pains [ Time Frame: 60 days from day -30 to day + 30 , once a week from Month 1 to month 6 ]
    the frequency of paroxysmal pains
  • Evaluate the effect of the intervention on quality of life: SF36 [ Time Frame: Day 1, 12, 90, 180 ]
    SF36
  • Evaluate the effect of the intervention on anxiety and depression [ Time Frame: Day 1, 12, 90, 180 ]
    HAD questionnaire
  • evaluating cortical plasticity [ Time Frame: Day 1, 12, 30 ]
    MRI analysis the physiopathological mechanisms governing phantom pain
  • evaluating cortical plasticity [ Time Frame: Day 1, 12, 30 ]
    EEG analysis the physiopathological mechanisms governing phantom pain
  • Evaluate the performance of subjects to control the neurofeedback system [ Time Frame: Day 1, 12, 30 ]
    Motor Imagery Questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brain Computer Interface and Virtual Reality (BCI-VR) for Pain Treatment
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuropathic Pain
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: BCI sessions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2019)		 7
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: vincent ROUALDES, MD 02 40 16 50 69 vincent.roulades@chu-nantes.fr
Contact: aurélien Van Langhenhove 02 40 16 51 73 aurelien.vanlanghenhove@chu-nantes.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03889353
Other Study ID Numbers  ICMJE RC17_0417
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Fondation Apicil
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP