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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Chronic Low Back Pain
• Intervention / Treatment: Other: Neurofeedback treatment; Other: functional magnetic resonance imaging (fMRI) scans

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arnaud Dupeyron; Phone Number: +33(0)4.66.68.34.59; Email: arnaud.dupeyron@gmail.com

Study Locations

• France
  • Nîmes, France, 30029
    • Recruiting
    • Nîmes University Hospital
    • Principal Investigator: Arnaud Dupeyron, MD-PhD
    • Sub-Investigator: Fabricio Pereira, PhD
    • Sub-Investigator: Isabel Tavares, MD
    • Contact: Anissa Megzari; Phone Number: +33 (0)4.66.68.42.36; Email: drc@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the cortical zone activated by neurofeedback	Measure taken by electroencephalography	Day 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back Beliefs Questionnaire (BBQ)	Auto-Questionnaire with 14 items describing the patient beliefs about chronic low back pain. The higher the score, the more the beliefs are negative	Day 20
Fear Avoidance Beliefs Questionnaire (FABQ)	Auto-Questionnaire with 16 items describing apprehension and avoidance in relation to professional activities and physical activities.	Day 20
Oswestry Disability Index (ODI)	Scale used to assess the functional disability of low back pain patients.	Day 20
Coping Strategies Questionnaire (CSQ)	Auto-Questionnaire with 21 items evaluating coping strategies specific to pain and especially in low back pain	Day 20
Hospital Anxiety and Depression Scale (HADS)	Auto-Questionnaire with 14 items used in the detection of anxio-depressive disorders. The higher the score, the more the depression is severe.	Day 20
Scale of lumbar pain in Quebec	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.	Day 20
Tampa scale	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.	Day 20

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Arnaud Dupeyron, MD, Nîmes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: NIMAO/2018-01/AD-01; 2021-A00437-34 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No