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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03889353
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : September 29, 2020
Sponsor:
Collaborator:
Fondation Apicil
Information provided by (Responsible Party):
Nantes University Hospital

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

Condition or disease Intervention/treatment Phase
Neuropathic Pain Device: BCI sessions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

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.




Primary Outcome Measures :
  1. 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%


Secondary Outcome Measures :
  1. 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

  2. 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


  3. 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

  4. 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).

  5. 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.

  6. evaluating cortical plasticity [ Time Frame: Day 1, 12, 30 ]
    MRI analysis the physiopathological mechanisms governing phantom pain

  7. evaluating cortical plasticity [ Time Frame: Day 1, 12, 30 ]
    EEG analysis the physiopathological mechanisms governing phantom pain

  8. Evaluate the performance of subjects to control the neurofeedback system [ Time Frame: Day 1, 12, 30 ]
    Motor Imagery Questionnaire



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889353


Contacts
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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

Locations
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France
Nantes Uh Recruiting
Nantes, France
Contact: Vincent ROUALDES, MD       vincent.roualdes@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Fondation Apicil
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03889353    
Other Study ID Numbers: RC17_0417
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations