Search / Trial NCT06234917

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

Launched by INSTITUT POUR LA PRATIQUE ET L'INNOVATION EN PSYCHOLOGIE APPLIQUÉE (INSTITUT PI-PSY) · Jan 22, 2024

Trial Information

Current as of October 08, 2024

Completed

Keywords

Eeg Neurofeedback Neuropathic Pain Peripheral Neuropathy Sensorimotor Rhythm Treatment

Description

1.1 - Description of the research proceedings and study design This is a single-centre, single-blinded, randomized controlled pilot study, in which 32 patients, aged between 18 and 80 years, suffering from painful peripheral neuropathy (DN4 and NRS pain scores ≥4/10), will be randomly assigned to one of the two following EEG-NFB protocols, aimed at increasing either the SMR/high-β ratio (n=16) or the μ/θ ratio (n=16) at central (rolandic) cortical level in a 1:1 allocation ratio, stratified by age and gender. The group allocation of the patients will be performed by one investigator not inv...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * 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.
  • Exclusion Criteria:
  • * Neurological disorder other than peripheral neuropathy (neurodegenerative disorders, migraine, epilepsy, stroke, tumor).
  • * Psychiatric illness.
  • * Major visual disturbance.
  • Exclusion Criteria:
  • -

About Institut Pour La Pratique Et L'innovation En Psychologie Appliquée (Institut Pi Psy)

The Institut pour la Pratique et l'Innovation en Psychologie Appliquée (Institut PI-Psy) is a leading clinical trial sponsor dedicated to advancing the field of applied psychology through rigorous research and innovative practices. Committed to enhancing mental health interventions, the institute collaborates with academic institutions and healthcare providers to conduct studies that address critical psychological challenges. By fostering a multidisciplinary approach, Institut PI-Psy aims to translate research findings into effective therapeutic strategies, ultimately improving patient outcomes and contributing to the development of evidence-based psychological practices.

Locations

Creteil, Ile De France, France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0