Pain ManagementNEVRNCT04551092

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

A study testing NEVR in people with Pain Management, run by Quantum Applied Science & Research, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 17 to 90 years
Conditions the study is for: Pain Management
What is being tested?: NEVR
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 7 Jan 2021to 31 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 17 to 90 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Altman Clinical and Translational Research Institute
San Diego, California, 92037

Other trials in United States

About this study

Official title: Neurofeedback-EEG-VR (NEVR) System for Non-opioid Pain Therapy

Read the detailed description

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: Pain Management
Being tested: NEVR
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NEVRDevice
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.

Study groups in NCT04551092
Study group	Role	What they receive
Single	Experimental	Single group to receive intervention Receives: Device: NEVR

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: up to 6 months

Secondary outcomes (4)

Changes in Pain Perception
The researchers will evaluate changes in pain perception over the course of the 20 sessions as determined by the pain questionnaires listed above. The researchers will plot the changes and calculate the percent change between the first to last measurement.
Measured: 6 months
Changes in EEG Activity Patterns
The researchers will calculate synchrony in electroencephalographic (EEG) alpha band (at 10Hz) across the temporal and central electrodes over the course of the 20 sessions. The researchers will compare the percentage of synchrony changes inter- and intra-sessions.
Measured: up to 6 months
Dose Response
The researchers will analyze the relationship between the number of sessions completed and the reported pain score of each of the three pain scales, as well as the EEG alpha synchrony. The research team will calculate a trendline to determine if there is a positive or negative trend and calculate a correlation index.
Measured: up to 6 months
Signal Quality
The researchers will also calculate the percentage of the acquired EEG signal that is deemed to be unusable due to contamination by noise or artifacts (other than EMG or blink artifacts), as defined by regions where the root mean square (RMS) signal amplitude exceeds 100 microV.
Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 202131 Mar 2022

First posted16 Sep 2020
Study start7 Jan 2021
Primary completion31 Mar 2022
Study completion31 Mar 2022

Why it stopped: Period of performance expired

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain ManagementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04551092
Sponsor's protocol ID: R43DA050380
Acronym: NEVR
Status last verified: Oct 2025
First submitted: 13 Jul 2020
Last updated: 10 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pain Management trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurofeedback-EEG-VR (NEVR) System for Non-opioid Pain Therapy
ClinicalTrials.gov ID: NCT04551092
Acronym / sponsor ID: NEVR / R43DA050380
Conditions: Pain Management
Study type: Interventional
Recruitment status: TerminatedReason stopped: Period of performance expired
Enrolment: 11 participants (actual)
Lead sponsor: Quantum Applied Science & Research, Inc.Industry (pharma, biotech, devices)
Collaborators: University of California, San Diego
Study start: 7 Jan 2021 (actual)
Primary completion: 31 Mar 2022 (actual)
Study completion: 31 Mar 2022 (actual)
First posted: 16 Sep 2020 (actual)
Results: Posted 10 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single	Experimental	Device: NEVRSingle group to receive intervention

Who may qualify

Ages: 17 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NEVRa non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.	Device	Single

Primary outcome

Percent of Patients Completing the Study
Time frame: up to 6 months
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.
Patient Tolerance of Device
Time frame: up to 6 months
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.
Adverse Effect on Pain
Time frame: up to 6 months
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.

4 secondary outcomes

Changes in Pain Perception
Time frame: 6 months
Changes in EEG Activity Patterns
Time frame: up to 6 months
Dose Response
Time frame: up to 6 months
Signal Quality
Time frame: up to 6 months

Results and safety

Results posted to the registry on 10 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NEVR Study	11	0

Primary outcome: Percent of Patients Completing the Study

Time frame: up to 6 months. Count of participants. Unit: Participants

Measure	NEVR Study n = 11
Value	0

Population analysed: Shortly after recruitment commenced, the study site was shut down for COVID and when re-opened it was a vaccine test site. The vaccine tests received priority and the study was not able to be conducted before the project period ended. No subjects completed the protocol and thus analysis was not able to be conducted.

Primary outcome: Patient Tolerance of Device

Time frame: up to 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	NEVR Study n = 4
Pressure Points	3 (.71)
Helmet Weight	5.25 (1.48)
Headset Tightness	6 (1.41)
Neck Muscle Tightness	7.5 (1.66)
Headache	6.5 (1.5)
Overall Comfort	6.75 (1.3)

Population analysed: 4 subjects only completed 1 session and no further sessions were conducted. Each subject reported on the 1-10 Comfort Scale for 6 measures. Subjects were asked to rate comfort for each of the 6 items on a scale from 1-10, where 1 was intolerable, 5 was just tolerable and 10 most comfortable. Higher values indicate a better comfort rating for that item. The mean values indicate the mean of the subjects' scores, as the goal is to produce a comprehensive comfort score per subject on a 1-10 scale.

Primary outcome: Adverse Effect on Pain

Time frame: up to 6 months

Population analysed: The assessments were not conducted prior to and after Session 1 for the 4 subjects who completed one session. The subject testing site was also a COVID treatment and vaccine testing site and the Subject Matter Expert was not available to conduct these assessments. There are no data for this measure.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NEVR Study	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lead organization websiteLink provided by the sponsor.
Subaward research siteLink provided by the sponsor.
NIH Funding InitiativeLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Pain Management

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Walid Soussou, PhD principal investigator

Quantum Applied Science & Research (QUASAR), Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NEVR in people with Pain Management, run by Quantum Applied Science & Research, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Patients Completing the Study (time frame: up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04551092.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.