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

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ClinicalTrials.gov Identifier: NCT03929952
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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 : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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




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.



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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.

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): NCT03929952


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 Not yet recruiting
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
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Principal Investigator: Arnaud Dupeyron, MD Nîmes University Hospital

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03929952     History of Changes
Other Study ID Numbers: NIMAO/2018-01/AD-01
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: January 2019

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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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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms