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| Name | Class |
|---|---|
| University of California, San Diego | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Experimental | Single group to receive intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walid Soussou, PhD | Quantum Applied Science & Research (QUASAR), Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Clinical and Translational Research Institute | San Diego | California | 92037 | United States |
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| Label | URL |
|---|---|
| Lead organization website | View source |
| Subaward research site | View source |
| NIH Funding Initiative | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | up to 6 months |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gayle Guy | Quantum Applied Science & Research, QUASAR Inc. | 858 412 1839 | gayle@quasarusa.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2020 | Apr 24, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2021 | Apr 24, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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 |
| Participants |
|
| Sex: Female, Male | Data not collected about 5 subjects. Signed consent but contact was lost after that. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Data not collected for 5 subjects. Subjects signed consent but follow up contact was unsuccessful. | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | up to 6 months |
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| Primary | 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. | 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. | Posted | up to 6 months |
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| Secondary | 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. | 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. | Posted | 6 months |
|
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| Secondary | 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. | 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. | Posted | up to 6 months |
|
|
| Secondary | 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. | No subjects completed the protocol. No subjects completed more than one session. Calculation not able to be conducted. | Posted | up to 6 months |
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| Secondary | 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. | 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. | Posted | up to 6 months |
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| 11 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Neck Muscle Tightness |
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| Headache |
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| Overall Comfort |
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