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Completed

NCT Number: NCT03889353

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

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

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes Uh

Nantes, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCI sessions

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Fondation Apicil

Registry information

Official study 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

Acronym: GHOST

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2019
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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