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

NCT ID: NCT03929952

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-19
• Study Completion Date: 2024-10-25

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.

Conditions

Low Back Pain; Chronic Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Chronic low back pain

Group Type: EXPERIMENTAL

Neurofeedback treatment

Intervention Type: OTHER

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.

functional magnetic resonance imaging (fMRI) scans

Intervention Type: OTHER

The patient in alpha synchrony related state and in rating state will undergo an fMRI

Interventions

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.

Intervention Type: OTHER

functional magnetic resonance imaging (fMRI) scans

The patient in alpha synchrony related state and in rating state will undergo an fMRI

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnaud Dupeyron, MD

Role: PRINCIPAL_INVESTIGATOR

Nîmes University Hospital

Locations

Nimes University Hospital

Nîmes, , France

Countries

France

Other Identifiers

2021-A00437-34

Identifier Type: OTHER

Identifier Source: secondary_id

NIMAO/2018-01/AD-01

Identifier Type: -

Identifier Source: org_study_id