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出境医 / 临床实验 / Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients (NEMOLOC)

Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients (NEMOLOC)

Study Description
Brief Summary:
This study aims to evaluate neurofeedback-induced changes in brain function and the correlations between these changes and clinical scores by functional magnetic resonance imaging and electroencephalography in patients with low back pain.

Condition or disease Intervention/treatment Phase
Low Back Pain Chronic Low Back Pain Other: Neurofeedback treatment Other: functional magnetic resonance imaging (fMRI) scans Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Chronic low back pain Other: Neurofeedback treatment

20 sessions of neurofeedback of 5 minutes each consisting of :

  • The patient is equipped with an electroencephalography headset. The feedback visual has the form of a candle flame and is modulated by alpha synchrony.
  • The height of the flame is proportional to the intensity of the patient's pain. The patient has to concentrate on the height of this flame by thought to modulate it and, at the same time, to decrease the intensity of his own pain.

Other: functional magnetic resonance imaging (fMRI) scans
The patient in alpha synchrony related state and in rating state will undergo an fMRI
Outcome Measures
Primary Outcome Measures :
  1. Description of the cortical zone activated by neurofeedback [ Time Frame: Day 20 ]
    Measure taken by electroencephalography


Secondary Outcome Measures :
  1. Back Beliefs Questionnaire (BBQ) [ Time Frame: Day 20 ]
    Auto-Questionnaire with 14 items describing the patient beliefs about chronic low back pain. The higher the score, the more the beliefs are negative

  2. Fear Avoidance Beliefs Questionnaire (FABQ) [ Time Frame: Day 20 ]
    Auto-Questionnaire with 16 items describing apprehension and avoidance in relation to professional activities and physical activities.

  3. Oswestry Disability Index (ODI) [ Time Frame: Day 20 ]
    Scale used to assess the functional disability of low back pain patients.

  4. Coping Strategies Questionnaire (CSQ) [ Time Frame: Day 20 ]
    Auto-Questionnaire with 21 items evaluating coping strategies specific to pain and especially in low back pain

  5. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Day 20 ]
    Auto-Questionnaire with 14 items used in the detection of anxio-depressive disorders. The higher the score, the more the depression is severe.

  6. Scale of lumbar pain in Quebec [ Time Frame: Day 20 ]
    Autoquestionnaire with 20 items used to measure the functional repercussions of low back pain on simple actions of everyday life. The higher the score, the more low back pains have a significant functional impact.

  7. Tampa scale [ Time Frame: Day 20 ]
    Autoquestionnaire with 17 items used to estimate the level of kinesiophobia (fear and fear) related to pain that leads to avoidance of activities considered to cause or increase pain or to cause or aggravate an injury. The higher the score, the higher the level of kinesiophobia.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with a wifi connexion at home
  • Patient with the ability to modulate the height of the candle by thinking in the alpha synchrony test.
  • Patient with chronic low back pain for more than six months with a visual analogue pain scale greater than 5 impacting activities of daily living, hobbies and work
  • Patient having given free and informed consent and signed consent.
  • Affected patient or beneficiary of a health insurance plan.
  • Patient who is at least 18 years old (≥) and younger than 75 years old (<).

Exclusion Criteria:

  • Pregnant or breastfeeding patient
  • Patient with a contraindication to performing a fMRI scan: ferromagnetic implant in the body, piercing, claustrophobia, unable to remain in the scanner stationary for 40 minutes
  • Patient already included in another study
  • Patient in a exclusion period determined by a previous study
  • The subject is under the protection of justice, guardianship or curatorship.
  • The subject refuses to sign the consent.
  • It is not possible to give the subject informed information.
Contacts and Locations

Contacts
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Contact: Arnaud Dupeyron +33(0)4.66.68.34.59 arnaud.dupeyron@gmail.com

Locations
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France
Nimes University Hospital
Nîmes, France, 30029
Contact: Anissa Megzari    +33 (0)4.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Arnaud Dupeyron, MD-PhD         
Sub-Investigator: Fabricio Pereira, PhD         
Sub-Investigator: Isabel Tavares, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Layout table for investigator information
Principal Investigator: Arnaud Dupeyron, MD Nîmes University Hospital
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date April 22, 2021
Estimated Study Start Date  ICMJE June 2021
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019) 		Description of the cortical zone activated by neurofeedback [ Time Frame: Day 20 ]
Measure taken by electroencephalography
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Back Beliefs Questionnaire (BBQ) [ Time Frame: Day 20 ]
    Auto-Questionnaire with 14 items describing the patient beliefs about chronic low back pain. The higher the score, the more the beliefs are negative
  • Fear Avoidance Beliefs Questionnaire (FABQ) [ Time Frame: Day 20 ]
    Auto-Questionnaire with 16 items describing apprehension and avoidance in relation to professional activities and physical activities.
  • Oswestry Disability Index (ODI) [ Time Frame: Day 20 ]
    Scale used to assess the functional disability of low back pain patients.
  • Coping Strategies Questionnaire (CSQ) [ Time Frame: Day 20 ]
    Auto-Questionnaire with 21 items evaluating coping strategies specific to pain and especially in low back pain
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Day 20 ]
    Auto-Questionnaire with 14 items used in the detection of anxio-depressive disorders. The higher the score, the more the depression is severe.
  • Scale of lumbar pain in Quebec [ Time Frame: Day 20 ]
    Autoquestionnaire with 20 items used to measure the functional repercussions of low back pain on simple actions of everyday life. The higher the score, the more low back pains have a significant functional impact.
  • Tampa scale [ Time Frame: Day 20 ]
    Autoquestionnaire with 17 items used to estimate the level of kinesiophobia (fear and fear) related to pain that leads to avoidance of activities considered to cause or increase pain or to cause or aggravate an injury. The higher the score, the higher the level of kinesiophobia.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients
Official Title  ICMJE Descriptive Pilot Study of the Effects of a Standardized Neuromodulation Program on Cortical Brain Function in Chronic Low Back Pain Patients
Brief Summary This study aims to evaluate neurofeedback-induced changes in brain function and the correlations between these changes and clinical scores by functional magnetic resonance imaging and electroencephalography in patients with low back pain.
Detailed Description Not Provided
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: Other
Condition  ICMJE
  • Low Back Pain
  • Chronic Low Back Pain
Intervention  ICMJE
  • Other: Neurofeedback treatment

    20 sessions of neurofeedback of 5 minutes each consisting of :

    • The patient is equipped with an electroencephalography headset. The feedback visual has the form of a candle flame and is modulated by alpha synchrony.
    • The height of the flame is proportional to the intensity of the patient's pain. The patient has to concentrate on the height of this flame by thought to modulate it and, at the same time, to decrease the intensity of his own pain.
  • Other: functional magnetic resonance imaging (fMRI) scans
    The patient in alpha synchrony related state and in rating state will undergo an fMRI
Study Arms  ICMJE Experimental: Chronic low back pain
Interventions:
  • Other: Neurofeedback treatment
  • Other: functional magnetic resonance imaging (fMRI) scans
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 24, 2019) 		15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient with a wifi connexion at home
  • Patient with the ability to modulate the height of the candle by thinking in the alpha synchrony test.
  • Patient with chronic low back pain for more than six months with a visual analogue pain scale greater than 5 impacting activities of daily living, hobbies and work
  • Patient having given free and informed consent and signed consent.
  • Affected patient or beneficiary of a health insurance plan.
  • Patient who is at least 18 years old (≥) and younger than 75 years old (<).

Exclusion Criteria:

  • Pregnant or breastfeeding patient
  • Patient with a contraindication to performing a fMRI scan: ferromagnetic implant in the body, piercing, claustrophobia, unable to remain in the scanner stationary for 40 minutes
  • Patient already included in another study
  • Patient in a exclusion period determined by a previous study
  • The subject is under the protection of justice, guardianship or curatorship.
  • The subject refuses to sign the consent.
  • It is not possible to give the subject informed information.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arnaud Dupeyron +33(0)4.66.68.34.59 arnaud.dupeyron@gmail.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929952
Other Study ID Numbers  ICMJE NIMAO/2018-01/AD-01
2021-A00437-34 ( Other Identifier: ANSM )
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nīmes
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnaud Dupeyron, MD Nîmes University Hospital
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date April 2021

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

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