Increasing Sensori-Motor Rhythm Activity by EEG-Neurofeedback to Reduce the Impact of Pain on Daily Functioning

NCT06234917 | Completed

• 1 other identifier: 2020-A00514-35
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Chronic neuropathic pain associated with peripheral neuropathies cannot be attributed solely to lesions of peripheral sensory axons and likely involves alteration in the processing of nociceptive information in the central nervous system in most patients. Few data are available regarding EEG correlates of chronic neuropathic pain. The fact is that effective cortical neuromodulation strategies to treat neuropathic pain target the precentral cortical region, i.e. a cortical area corresponding to the motor cortex. It is not known how these strategies might modulate brain rhythms in the central cortical region, but it can be speculated that sensorimotor rhythms (SMRs) are modified. Another potent way of modulating cortical rhythms is to use EEG-based neurofeedback (NFB). Rare studies previously aimed at relieving neuropathic pain using EEG-NFB training. Methods/Design: The objective of this single-centre, single-blinded, randomized controlled pilot study is to assess the value of an EEG-NFB procedure to relieve chronic neuropathic pain in patients with painful peripheral neuropathy. A series of 32 patients will be randomly assigned to one of the two following EEG-NFB protocols, aimed at increasing either the low-β(SMR)/high-β ratio (n=16) or the α(μ)/θ ratio (n=16) at central (rolandic) cortical level. Various clinical outcome measures will be collected before and one week after 12 EEG-NFB sessions performed over 4 weeks. Resting-state EEG will also be recorded immediately before and after each NFB session. The primary endpoint will be the change in the impact of pain on patient\'s daily functioning, as assessed on the Interference Scale of the short form of the Brief Pain Inventory. Discussion: The value of EEG-NFB procedures to relieve neuropathic pain has been rarely studied. This pilot study will attempt to show the value of endogenous modulation of brain rhythms in the central (rolandic) region in the frequency band corresponding to the frequency of stimulation currently used by therapeutic motor cortex stimulation. In the case of significant clinical benefit produced by the low-β(SMR)/high-β ratio increasing strategy, this work could pave the way for using EEG-NFB training within the armamentarium of neuropathic pain therapy.

Conditions

Chronic Pain Syndrome; Peripheral Neuropathic Pain

Keywords

EEG; neurofeedback; neuropathic pain; peripheral neuropathy; sensorimotor rhythm; treatment

Outcome Measures

Primary Outcomes (1)

• Interference Scale of the short form of the Brief Pain Inventory (BPI)

  The 7-item Interference Scale of the short form of the Brief Pain Inventory measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. It uses a 0 to 10 numeric rating scales for each item rating. The minimum score is 0 (no interference of pain on daily living activities, ie better outcome) and the maximum score is 70 (maximal interference of pain on daily living activities, ie worse outcome).

  From enrollment to 7 days after the last NFB session

Secondary Outcomes (10)

• Average intensity of daily ongoing pain on a 0-10 numeric rating scale (NRS)

  From enrollment to 7 days after the last NFB session

• Average intensity of daily ongoing pain on a 0-5 verbal rating scale (VRS)

  From enrollment to 7 days after the last NFB session

• Symptomatic profile of neuropathic pain on the Neuropathic Pain Symptom Inventory (NPSI)

  From enrollment to 7 days after the last NFB session

• Tendency to catastrophizing on the Pain Catastrophizing Scale (PCS)

  From enrollment to 7 days after the last NFB session

• Anxiety and depression on the Hospital Anxiety and Depression scale (HAD)

  From enrollment to 7 days after the last NFB session

Study Arms (2)

EEG-NFB protocol aimed at increasing the low-β(SMR)/high-β ratio

EXPERIMENTAL

EEG neuromodulation at central (rolandic) cortical level

Other: EEG-based neurofeedback for brain activity modulation

EEG-NFB protocol aimed at increasing the α(μ)/θ ratio

ACTIVE COMPARATOR

EEG neuromodulation at central (rolandic) cortical level

Other: EEG-based neurofeedback for brain activity modulation

Interventions

EEG-based neurofeedback for brain activity modulation OTHER

NFB is a type of biofeedback technique for self-modulating brain activities by means of a learning task performed with ongoing sensory (usually visual) feedback to real-time acquisition of either brain imaging or electroencephalographic (EEG) signal, which serves as a biomarker of brain activity

EEG-NFB protocol aimed at increasing the low-β(SMR)/high-β ratio; EEG-NFB protocol aimed at increasing the α(μ)/θ ratio

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Definite peripheral neuropathy on both clinical and neurophysiological grounds, present for at least 6 months.
• Neuropathic pain clearly related to the neuropathy, as defined by a score ≥ 4/10 on the DN4 questionnaire.
• Score ≥ 4/10 on a 0-10 numerical rating scale (NRS) concerning the average intensity of daily ongoing pain.
• Age between 18 and 80 years.
• Affiliation with the social security system.
• Ability to provide signed informed consent.

You may not qualify if:

• Neurological disorder other than peripheral neuropathy (neurodegenerative disorders, migraine, epilepsy, stroke, tumor).
• Psychiatric illness.
• Major visual disturbance.

Sponsors & Collaborators

• Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy): lead

Study Sites (1)

Henri Mondor University Hospital

Créteil, Île-de-France Region, 94000, France

Location

MeSH Terms

Conditions

Neuralgia; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of PiPsy Institute

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 31, 2024
• Study Start: January 4, 2021
• Primary Completion: December 16, 2022
• Study Completion: February 1, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)