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

Centre Hospitalier Universitaire de Nīmes1 site in 1 country15 target enrollmentJanuary 19, 2022

ConditionsLow Back Pain Chronic Low Back Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Low Back Pain
Sponsor: Centre Hospitalier Universitaire de Nīmes
Enrollment: 15
Locations: 1
Primary Endpoint: Description of the cortical zone activated by neurofeedback
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 19, 2022

End Date

October 25, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nīmes

Responsible Party

Sponsor

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.