Trial Outcomes & Findings for Neurofeedback-EEG-VR System for Non-opioid Pain Therapy (NCT NCT04551092)

Last Updated: 2025-11-10

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

up to 6 months

Results posted on

2025-11-10

Participant Flow

Participant milestones

Participant milestones
Measure	NEVR Study Single group to receive intervention 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.
Overall Study STARTED	11
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	NEVR Study Single group to receive intervention 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.
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Data not collected about 5 subjects. Signed consent but contact was lost after that.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NEVR Study n=11 Participants Single group to receive intervention 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.
Age, Categorical <=18 years	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=11 Participants
Age, Categorical >=65 years	0 Participants n=11 Participants
Sex: Female, Male Female	5 Participants n=6 Participants • Data not collected about 5 subjects. Signed consent but contact was lost after that.
Sex: Female, Male Male	1 Participants n=6 Participants • Data not collected about 5 subjects. Signed consent but contact was lost after that.
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=11 Participants • Data not collected for 5 subjects. Subjects signed consent but follow up contact was unsuccessful.
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=11 Participants • Data not collected for 5 subjects. Subjects signed consent but follow up contact was unsuccessful.
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=11 Participants • Data not collected for 5 subjects. Subjects signed consent but follow up contact was unsuccessful.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants
Race (NIH/OMB) Asian	0 Participants n=11 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants
Race (NIH/OMB) Black or African American	1 Participants n=11 Participants
Race (NIH/OMB) White	5 Participants n=11 Participants
Race (NIH/OMB) More than one race	0 Participants n=11 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=11 Participants
Region of Enrollment United States	11 participants n=11 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	NEVR Study n=11 Participants Single group to receive intervention 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.
Percent of Patients Completing the Study	0 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	NEVR Study n=4 Participants Single group to receive intervention 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.
Patient Tolerance of Device Pressure Points	3 score on a scale Standard Deviation .71
Patient Tolerance of Device Helmet Weight	5.25 score on a scale Standard Deviation 1.48
Patient Tolerance of Device Headset Tightness	6 score on a scale Standard Deviation 1.41
Patient Tolerance of Device Neck Muscle Tightness	7.5 score on a scale Standard Deviation 1.66
Patient Tolerance of Device Headache	6.5 score on a scale Standard Deviation 1.5
Patient Tolerance of Device Overall Comfort	6.75 score on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: up to 6 months

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Only 4 subjects completed any sessions and each of these only completed one session. Thus it was not possible to plot a change from session to session. There are no data for this outcome.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months

Population: No subjects completed the protocol. Only 4 subjects did one session each. The data from these subjects were not adequate to conduct this calculation and no further sessions were conducted in which to revise the collection methodology to ensure adequate collection. Comfort survey data were collected but EEG data were not properly saved by the researchers and thus were not usable.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months

Population: No subjects completed the protocol. No subjects completed more than one session. Calculation not able to be conducted.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 months

Population: A researcher error in using the data collection software meant that EEG data for the 4 participants who did one session were not saved properly to be transmitted to QUASAR scientists for analysis. Training for the researcher was rectified once the issue was identified but no more sessions were conducted after that. There are no data for this outcome.

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.

Outcome measures

Outcome data not reported

Adverse Events

NEVR Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gayle Guy

Quantum Applied Science & Research, QUASAR Inc.

Phone: 858 412 1839

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place