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

NCT04551092 | Terminated Results FDA Device

• 1 other identifier: R43DA050380
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (3)

• Percent of Patients Completing the Study

  The researchers will calculate the percentage of patients who complete all 20 sessions of the study without any adverse effects nor any discomfort from the device or VR.

  up to 6 months

• Patient Tolerance of Device

  The researchers will survey the subjects about their comfort of wearing the device after each session on a scale of 1-10, where 1 is intolerable, 5 is just tolerable, and 10 is most comfortable. The researchers refer to this as the Comfort Scale.

  up to 6 months

• Adverse Effect on Pain

  Subjects' back pain will be assessed prior to and after the first, 10th and last sessions via the following standardized subjective, objective, behavioral and functional evaluation tests: 1) Numerical Rating Scale (NRS, or Visual Analog Pain Score (VAS), 2) The DALLAS scale; 3) Patient Assessment Global Change. The researchers will compare the before and after session results to determine if the sessions had a negative impact on the patients' perceived pain.

  up to 6 months

Secondary Outcomes (4)

• Changes in Pain Perception

  6 months

• Changes in EEG Activity Patterns

  up to 6 months

• Dose Response

  up to 6 months

• Signal Quality

  up to 6 months

Study Arms (1)

Single

EXPERIMENTAL

Single group to receive intervention

Device: NEVR

Interventions

NEVR 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.

Single

Eligibility Criteria

• Age: 17 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quantum Applied Science & Research, Inc.: lead
• University of California, San Diego: collaborator

Study Sites (1)

Altman Clinical and Translational Research Institute

San Diego, California, 92037, United States

Location

Related Links

• Lead organization website
• Subaward research site
• NIH Funding Initiative

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Gayle Guy
• Organization: Quantum Applied Science & Research, QUASAR Inc.

gayle@quasarusa.com

858 412 1839

Study Officials

• Walid Soussou, PhD

  Quantum Applied Science & Research (QUASAR), Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: September 16, 2020
• Study Start: January 7, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Locations

US (1)