Clinical trial NCT04551092: Neurofeedback-EEG-VR System for Non-opioid Pain Therapy
Official title: Neurofeedback-EEG-VR (NEVR) System for Non-opioid Pain Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Lead sponsor: Quantum Applied Science & Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Diego
First posted: 2020-09-16
Enrollment: 11
Sex: ALL
Minimum age (years): 17
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of patients completing the study
timeFrame: up to 6 months
measure: Patient Tolerance of Device
timeFrame: up to 6 months
measure: Adverse Effect on Pain
timeFrame: up to 6 months
Secondary outcomes:
measure: Changes in Pain Perception
timeFrame: 6 months
measure: Changes in EEG activity patterns
timeFrame: up to 6 months
measure: Dose Response
timeFrame: up to 6 months
measure: Signal Quality
timeFrame: up to 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
Study officials:
affiliation: Quantum Applied Science & Research (QUASAR), Inc.
name: Walid Soussou, PhD
role: PRINCIPAL_INVESTIGATOR
References: