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

Study Overview
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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.

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

Conditions
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Pain Management

Intervention / Treatment
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* Device: NEVR


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single<br>Single group to receive intervention | Device: NEVR<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | up to 6 months |