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Neurofeedback-EEG-VR System for Non-opioid Pain Therapy

NCT ID: NCT04551092

Last Updated: 2025-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2022-03-31

Brief Summary

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This study will assess the feasibility of developing the Neurofeedback-EEG-VR (NEVR) system for non-opioid pain therapy. Subjects suffering from pain will undergo sessions involving VR and Neurofeedback training and their pain will be assessed.

Detailed Description

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QUASAR and UCSD are conducting a clinical trial on 25 subjects to evaluate the feasibility of a novel Neurofeedback electroencephalography (EEG) Virtual Reality (VR) system aimed at reducing chronic pain. The NEVR device consists of a dry electrode EEG headset combined with a VR Head-Mounted Display (VR-HMD) device and neurofeedback software. This approach relies on retraining the brain's networks to reduce the perception of pain and does not involve pharmaceutical drugs. Patients with chronic lower back pain will be recruited by UCSD at its Altman Clinical \& Translational Research Institute. Patients that meet the recruitment criteria will be asked to conduct 20 1-hour long sessions of EEG-based Neurofeedback in VR over the course of a couple of months. Pain assessment and device usability questionnaires will be conducted prior to and after the first and last sessions, and at intermediate time points. This will be a single arm clinical trial aimed at demonstrating the safety and viability of the NEVR device, with the primary outcome measure being the ability of patients to conduct all 20 sessions safely and comfortably. Secondary outcome measures include assessment of changes in pain perception, and of changes in EEG activity patterns.

Conditions

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Pain Management

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single

Single group to receive intervention

Group Type EXPERIMENTAL

NEVR

Intervention Type DEVICE

a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.

Interventions

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NEVR

a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Chronic back pain that can be of multifactorial etiology inclusive of axial and radicular back pain
* Report a Numerical Rating Scale (NRS, or Visual Analog Score VAS) score of greater than 6/10
* Must be willing to for the duration of the study make no pharmacological adjustments or have additional Interventional therapies, as reported by the patient
* Must have the cognitive capacity to provide consent/assent
* Must be able to sit up in a chair during the recording session
* Must demonstrate understanding of the protocol, its purpose and subject participation
* Must be fluent in English

Exclusion Criteria

* Measured head size too small or too large for the EEG equipment
* Any significant skull defect
* History of a recent craniotomy (within the last six months)
* Any signs of scalp inflammation, irritation, or abnormal skin conditions
* History of epilepsy or seizures
* Known allergies to any material to be used in this project
* Sight disabilities that make participation impractical
* Hair styles with thick braids or dread locks
Minimum Eligible Age

17 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role collaborator

Quantum Applied Science & Research, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Walid Soussou, PhD

Role: PRINCIPAL_INVESTIGATOR

Quantum Applied Science & Research (QUASAR), Inc.

Locations

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Altman Clinical and Translational Research Institute

San Diego, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.quasarusa.com

Lead organization website

https://actri.ucsd.edu/index.html

Subaward research site

http://heal.nih.gov

NIH Funding Initiative

Other Identifiers

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R43DA050380

Identifier Type: NIH

Identifier Source: org_study_id

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