Chronic PainPhase 2CBOT-P-2NCT06671132
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)
A Phase 2 study testing Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain and Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) in people with Chronic Pain and Low Back Pain, run by Evon Medics LLC at 2 sites in United States.
Trial summary
The overarching goal of this study phase, Phase II component is to perform a randomized clinical trial of the refined Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain [CBOT-Pain (or CBOT-P)] from Phase I, compared to sham Computerized Chemosensory-Based Orbitofrontal Networks… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Pain, Low Back Pain
- What is being tested?
- Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain and Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Oct 2024to 30 Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-85.
- Pain duration > 6 months.
- Must meet the minimum criteria for cognitive function using the PROMIS 4-item cognitive screener >3.
- Average pain score of > 5/10, with low back pain being the primary pain site. (5) CLBP (chronic low back pain) meeting Quebec Task Force Classification System Categories I-III.
- Evidence of a prior lumbar spine X-ray to rule out red flags, such as infection, tumor, or fracture.
- For those taking opioids (the opioid subgroup), participants must be prescribed opioids currently for at least 3 consecutive months prior to enrollment. Such patients must be on opioids for a minimum of three months, taking them daily or intermittently during the week. (8) Subject must agree that opioids cannot be increased during the study. (9) No substance use disorder (SUD), except tobacco in the past year based on substance screening survey and frequent urine toxicology screens. (10) No acute suicidality, mania, or psychosis. This will be assessed at study entry, which will also include a review of history in the EHR, Diagnostic Interview for Genetic Studies (DIGS) and Columbia Suicide Severity Rating scale (C-SSRS) and (11) Finally, participants must sign IRB-approved consent.
Who cannot join
- Back surgery within the past six months.
- Active worker's compensation or litigation claims.
- New pain and/or psychiatric treatments within 2 weeks of enrollment.
- Intent to add new or increase pain treatments during the study period, such as back surgery, nerve block procedures, or medications.
- Intent to add new psychiatric treatments during the first 3 months of the study.
- Any clinically unstable systemic illness that is judged to interfere with the trial.
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- History of cardiac, nervous system, or respiratory disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for respiratory depression.
- Non-ambulatory status.
- Pregnancy or the intent to become pregnant during the study. Women of childbearing age will have urine pregnancy testing at enrollment and monthly. (10) Anosmia or significant nasal disease
- Contraindications to MRI (12) Stroke or TBI (traumatic brain injury).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Global Pain Management LLC
Pasadena, Maryland, 21112
Opeyemi Awofeso, MD, 410-891-4007 ext. 1, oawofeso@evonmedics.org
Vaishnavi Varma, BS, 404-991-8424, oawofeso@evonmedics.org
- Recruiting
Howard University
Washington D.C., District of Columbia, 20060
Maria Hipolito, MD, 202-865-1751, mhipolito@howard.edu
Narayan Rai, MD, 202-865-1867, narayan.rai@howard.edu
About this study
Official title: Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-Pain) Testing Phase
The overarching goal of this study phase, Phase II component is to perform a randomized clinical trial of the refined Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain [CBOT-Pain (or CBOT-P)] from Phase I, compared to sham Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) in Chronic Low Back Pain (CLBP) to determine its short- and long-term effectiveness on Pain, Negative Affect (NA), Cognition and Cortical Brain Structure (PACS), long-term safety, and indications.
The investigators will perform a randomized clinical trial of the refined CBOT-P from Phase I, compared to sham CBOT in CLBP.
Read more
Aim 2.1: To determine if CBOT-P significantly influences: (1) acute and long-term reduction of pain severity, and (2) acute and long-term reduction of negative affect. The hypothesis is that optimized CBOT will produce faster, stronger, and longer-lasting improvements in pain severity, NA severity, cognitive impairments, and sleep and functional outcomes.
Aim 2.2 To determine if CBOT-P significantly prevents or reduces progressive shrinkage in the orbitofrontal cortex (OFC), cingulate cortex, and hippocampus. MRI will be acquired at baseline and 6th month. An integrative analysis will be conducted to determine the link between changes in brain structure and cognitive trajectory. The hypothesis is that the CBOT optimized with BCP significantly attenuates shrinkage in OFC and other prefrontal cortex (PFC) regions, compared to the Sham intervention.
Read the detailed description
The Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P) is a project to develop an effective, scalable, user-friendly, and home-based neuromodulatory platform for broad-spectrum treatment of chronic pain conditions with associated negative affect and cognitive impairments.
The small business, Evon Medics created the olfactory pulsing technology called Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT-P) to enable home-based modulation of the OFC and subcortical limbic structures to treat pain and negative affect. In a stakeholder value canvassing exercise chronic pain (CP) sufferers and pain doctors unanimously desire new non-invasive, home-based, safe, and effective interventions that can reduce pain severity by more than 10%, suggesting that current treatments have limitations. Anterograde and retrograde anatomical tracings have been used to demonstrate direct (monosynaptic) anatomical connection between the OFC and the descending inhibitory pain nodes at the midbrain periaqueductal gray matter (PAG). Transition to CP is marked by weakened modulation of the PAG descending inhibition.
In this study phase, Phase II of this Fast-Track SBIR application, the investigators will conduct a multi-site study of 220 adult patients with CLBP to establish stronger evidence that the product controls pain, reduces negative mood, improves cognition, and protects the brain from shrinking in six months of treatment. Participants in this phase will be randomly assigned in a 1:1 ratio to daily treatment with CBOT-P device (i.e., CBOT with beta-caryophyllene (BCP) compared to a control (Sham) device that looks like the device but does not have the active ingredients and the programmed parameters on the ability to improve pain, mood, cognition and brain functions in chronic pain. Structural magnetic resonance imaging (MRI) will be acquired at baseline and after 6 months of daily treatment with optimized CBOT (based on Phase I) or Sham CBOT device to improve masking. Pain and NA measures, Cognitive batteries, and physical and functional measures will be assessed at baseline, months 1, 3, and 6. Participants would be encouraged through mobile health prompts to complete subjective pain, affect, sleep, and functional studies at the end of each study week. CLBP volunteers, radiologists, and clinicians assessing outcome measures will be blinded to these assignments.
The investigators will also collect user experiences to help refine a final marketable CBOT product, enter the FDA breakthrough designation program for pain that would lead to Medicare/Medicaid reimbursement, engage a wider network of pain stakeholders, and establish marketing for commercial success.
- Conditions
- Chronic Pain, Low Back Pain
- Being tested
- Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain, Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)
- Keywords
- Chronic pain, Pain, Negative Affect, Cognitive Impairments, Attenuation of Structural Brain Loss in CP with high NA, PACS outcome, Orbitofrontal Cortex, Chemosensory-Based Orbitofrontal Networks Training
- Medical subject headings
- Chronic Pain, Low Back Pain, Pain, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Chemosensory-Based Orbitofrontal Cortex Training for PainCombination product
Also called CBOT-P, CBOT device with BCP
CBOT device with beta-caryophyllene
Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)Combination product
Also called CBOT device
CBOT device administering continuous olfactoy stimuli with no BCP
| Study group | Role | What they receive |
|---|---|---|
| CBOT-P [CBOT + beta caryophyllene (BCP)] | Experimental | CBOT device with BCP Receives: Combination Product: Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain |
| Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) | Sham comparator | CBOT device Receives: Combination Product: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1)
Change in 11-point score PROMIS Numeric Rating Scale v1.0 - Pain Intensity from baseline.
The Numeric Rating Scale measures each consist of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain).
Measured: Baseline to month 1 visit
Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1)
Change in negative affect score from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Measured: Baseline to month 1 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1)
Change in 11-point score PROMIS Numeric Rating Scale v1.0 - Pain Intensity from baseline.
The Numeric Rating Scale measures each consist of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain).
Measured: Baseline to month 3 visit
Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1)
Change in negative affect score from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Measured: Baseline to month 3 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1)
Change in 11-point score PROMIS Numeric Rating Scale v1.0 - Pain Intensity from baseline.
The Numeric Rating Scale measures each consist of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain).
Measured: Baseline to month 6 visit
Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1)
Change in negative affect score from the PANAS rating scale
It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.
Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Measured: Baseline to month 6 visit
Grey Matter Volumes of OrbitoFrontal Cortex and Hippocampus Aim 2.2
Change in the structural brain MRI baseline grey matter volumes of the orbitofrontal cortex and hippocampus at 6 months.
The investigators will use linear mixed effect and coefficient measures, and include sex, age, opioid medications, and duration of CP as confounders and as effect modifiers. Investigators will also estimate linear and non-linear trajectories.
Measured: Baseline and 6 months
Secondary outcomes (31)
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference scores. Aim 2.1
Change in PROMIS Short Form v1.1 - Pain Interference scores.
The PROMIS Pain Interference Short Form 4a is consists of 4 questions, each question usually has five response options ranging in value from one to five. The lowest possible raw score is 4; the highest possible raw score is 20.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 1 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 2.1
Change in PROMIS Short Form v1.0 - Anxiety scores
The PROMIS Anxiety 1a is consists of 55 questions, each question usually has five response options ranging in value from one to five. The lowest possible raw score is 55; the highest possible raw score is 275.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 1 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 2.1
Change in PROMIS Short Form v1.0 - Sleep Disturbance scores
The PROMIS Sleep Disturbance v1.0 is consists of 26 questions, each question usually has five response options ranging in value from one to five. The lowest possible raw score is 26; the highest possible raw score is 130.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 1 visit
Total Sleep Time (TST) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Total Sleep Time (TST) captured by Centrepoint Insight Actigraph watch:
The total sleep time is the total amount of sleep time scored during the total recording time. This includes time from sleep onset to sleep offset and is distributed throughout the sleep time as minutes of Stage N1 sleep, Stage N2 sleep, Stage N3, and rapid eye movement (REM) sleep. All these times are described in minutes.
A low total sleep time may indicate that the patient slept for an insufficient period of time due to non-medical/non-physiological reasons, certain medical or sleep disorders, or as a result of the effect of medications. Long total sleep time may suggest prior sleep deprivation, medical conditions, or effects of medications.
Measured: Baseline and 1 month
Sleep Onset Latency (SOL) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Sleep Onset Latency (SOL) captured by Centrepoint Insight Actigraph watch:
Sleep latency is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch scored as sleep.
Sleep latency also indicates if reasonable attention was paid to the patient's sleep diary and the 'lights out' time was close to the patient's routine bedtime at home. Clearly, if the lights are turned out earlier than the patient's usual bedtime, sleep latency would be spuriously long, and the patient may not fall asleep until his/her usual sleep time is reached. Similarly, if the 'lights out' time is later than the patient's usual bedtime, the patient will be sleepy and a spuriously short sleep latency will be recorded. It is of utmost importance that the patient's usual habitual sleep time is incorporated into the patient's sleep study design and 'lights out' time is approximated.
Measured: Baseline and 1 month
Sleep Efficiency (SE) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Sleep Efficiency (SE) captured by Centrepoint Insight Actigraph watch:
Sleep efficiency refers to percentage of total time in bed actually spent in sleep calculated as sum of Stage N1, Stage N2, Stage N3, and REM sleep, divided by the total time in bed and multiplied by 100.
Sleep efficiency gives an overall sense of how well the patient slept, but it does not distinguish frequent, brief episodes of wakefulness. A low sleep efficiency percentage could result from long sleep latency and long sleep offset to lights on time with otherwise normal quantity and quality of sleep in between. Many laboratories report total wake time, that is, the amount of wake time during the total recording time in minutes after the sleep onset. The total amount gives a general estimation for overall quality of sleep. Total wake time is the reciprocal of total sleep time. A high total sleep time percent is always associated with low total wake time percent and vice versa
Measured: Baseline and 1 month
Wake After Sleep Onset (WASO) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Wake After Sleep Onset (WASO) captured by Centrepoint Insight Actigraph watch:
Wake after sleep onset, also known as 'WASO' refers to periods of wakefulness occurring after defined sleep onset. This parameter measures wakefulness, excluding the wakefulness occurring before sleep onset. WASO time is a better reflection of sleep fragmentation.
Measured: Baseline and 1 month
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function Aim 2.1
Change in PROMIS Short Form v2.0 - Physical Function score
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. The PROMIS short form v2.0 Physical function instrument is consists of 22 questions, each question has five response options ranging in value from one to five. The lowest possible raw score is 22 and the highest possible raw score is 113.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 1 visit
Patient Global Impression of Change Aim 2.1
Change in Patient Global Impression of Change score
The Patient Global Impression of Change scale is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time. It is a patient-reported outcome measure that can be used to assess treatment benefit in clinical trials or practice. It is based on the Clinical Global Impression of Change scale, which is an observer-rated scale of symptom severity and treatment response. The scale ranges from 1 (no change or worse) to 7 (a great deal better).
Measured: Baseline to month 1 visit
California Verbal Learning Test (CVLT) Aim 2.1
The California Verbal Learning Test - Third Edition (CVLT-III) is a comprehensive assessment of verbal learning and memory. It produces a variety of scores, including:
d' score A raw score that reflects the difference between the hit rate (signal) and the false positive (FP) rate (noise). The d' score is calculated by subtracting the FP rate from the hit rate, after applying a z-transform to each.
Total RD A score that can range from +4.0 to -4.0. A high score indicates a high number of hits and a low number of FP errors, while a low score indicates a low number of hits and a high number of FP errors.
Scaled scores Scores that are adjusted for age and gender using the CVLT-3 standardization sample norms.
T-scores Scores that are derived from scaled scores and demographic information using look-up tables. T-scores are a comparison of an individual's memory performance to what is expected based on their demographics.
Measured: Baseline to month 1 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference scores. Aim 2.1
Change in PROMIS Short Form v1.1 - Pain Interference scores.
The PROMIS Pain Interference Short Form 4a is consists of 4 questions, each question usually has five response options ranging in value from one to five. The lowest possible raw score is 4; the highest possible raw score is 20.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 3 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 2.1
Change in PROMIS Short Form v1.0 - Anxiety scores
The PROMIS Anxiety 1a is consists of 55 questions, each question usually has five response options ranging in value from one to five. The lowest possible raw score is 55; the highest possible raw score is 275.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 3 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 2.1
Change in PROMIS Short Form v1.0 - Sleep Disturbance scores
The PROMIS Sleep Disturbance v1.0 is consists of 26 questions, each question usually has five response options ranging in value from one to five. The lowest possible raw score is 26; the highest possible raw score is 130.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 3 visit
Total Sleep Time (TST) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Total Sleep Time (TST) captured by Centrepoint Insight Actigraph watch:
The total sleep time is the total amount of sleep time scored during the total recording time. This includes time from sleep onset to sleep offset and is distributed throughout the sleep time as minutes of Stage N1 sleep, Stage N2 sleep, Stage N3, and rapid eye movement (REM) sleep. All these times are described in minutes.
A low total sleep time may indicate that the patient slept for an insufficient period of time due to non-medical/non-physiological reasons, certain medical or sleep disorders, or as a result of the effect of medications. Long total sleep time may suggest prior sleep deprivation, medical conditions, or effects of medications.
Measured: Baseline and month 3
Sleep Onset Latency (SOL) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Sleep Onset Latency (SOL) captured by Centrepoint Insight Actigraph watch:
Sleep latency is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch scored as sleep.
Sleep latency also indicates if reasonable attention was paid to the patient's sleep diary and the 'lights out' time was close to the patient's routine bedtime at home. Clearly, if the lights are turned out earlier than the patient's usual bedtime, sleep latency would be spuriously long, and the patient may not fall asleep until his/her usual sleep time is reached. Similarly, if the 'lights out' time is later than the patient's usual bedtime, the patient will be sleepy and a spuriously short sleep latency will be recorded. It is of utmost importance that the patient's usual habitual sleep time is incorporated into the patient's sleep study design and 'lights out' time is approximated.
Measured: Baseline and month 3
Sleep Efficiency (SE) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Sleep Efficiency (SE) captured by Centrepoint Insight Actigraph watch:
Sleep efficiency refers to percentage of total time in bed actually spent in sleep calculated as sum of Stage N1, Stage N2, Stage N3, and REM sleep, divided by the total time in bed and multiplied by 100.
Sleep efficiency gives an overall sense of how well the patient slept, but it does not distinguish frequent, brief episodes of wakefulness. A low sleep efficiency percentage could result from long sleep latency and long sleep offset to lights on time with otherwise normal quantity and quality of sleep in between. Many laboratories report total wake time, that is, the amount of wake time during the total recording time in minutes after the sleep onset. The total amount gives a general estimation for overall quality of sleep. Total wake time is the reciprocal of total sleep time. A high total sleep time percent is always associated with low total wake time percent and vice versa
Measured: Baseline and month 3
Wake After Sleep Onset (WASO) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Wake After Sleep Onset (WASO) captured by Centrepoint Insight Actigraph watch:
Wake after sleep onset, also known as 'WASO' refers to periods of wakefulness occurring after defined sleep onset. This parameter measures wakefulness, excluding the wakefulness occurring before sleep onset. WASO time is a better reflection of sleep fragmentation.
Measured: Baseline and month 3
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function Aim 2.1
Change in PROMIS Short Form v2.0 - Physical Function score
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. The PROMIS short form v2.0 Physical function instrument is consists of 22 questions, each question has five response options ranging in value from one to five. The lowest possible raw score is 22 and the highest possible raw score is 113.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 3 visit
Patient Global Impression of Change Aim 2.1
Change in Patient Global Impression of Change score
The Patient Global Impression of Change scale is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time. It is a patient-reported outcome measure that can be used to assess treatment benefit in clinical trials or practice. It is based on the Clinical Global Impression of Change scale, which is an observer-rated scale of symptom severity and treatment response. The scale ranges from 1 (no change or worse) to 7 (a great deal better).
Measured: Baseline to month 3 visit
California Verbal Learning Test (CVLT) Aim 2.1
The California Verbal Learning Test - Third Edition (CVLT-III) is a comprehensive assessment of verbal learning and memory. It produces a variety of scores, including:
d' score A raw score that reflects the difference between the hit rate (signal) and the false positive (FP) rate (noise). The d' score is calculated by subtracting the FP rate from the hit rate, after applying a z-transform to each.
Total RD A score that can range from +4.0 to -4.0. A high score indicates a high number of hits and a low number of FP errors, while a low score indicates a low number of hits and a high number of FP errors.
Scaled scores Scores that are adjusted for age and gender using the CVLT-3 standardization sample norms.
T-scores Scores that are derived from scaled scores and demographic information using look-up tables. T-scores are a comparison of an individual's memory performance to what is expected based on their demographics.
Measured: Baseline to month 3 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference scores. Aim 2.1
Change in PROMIS Short Form v1.1 - Pain Interference scores.
The PROMIS Pain Interference Short Form 4a is consists of 4 questions, each question usually has five response options ranging in value from one to five. The lowest possible raw score is 4; the highest possible raw score is 20.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 6 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 2.1
Change in PROMIS Short Form v1.0 - Anxiety scores
The PROMIS Anxiety 1a is consists of 55 questions, each question usually has five response options ranging in value from one to five. The lowest possible raw score is 55; the highest possible raw score is 275.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 6 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 2.1
Change in PROMIS Short Form v1.0 - Sleep Disturbance scores
The PROMIS Sleep Disturbance v1.0 is consists of 26 questions, each question usually has five response options ranging in value from one to five. The lowest possible raw score is 26; the highest possible raw score is 130.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 6 visit
Total Sleep Time (TST) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Total Sleep Time (TST) captured by Centrepoint Insight Actigraph watch:
The total sleep time is the total amount of sleep time scored during the total recording time. This includes time from sleep onset to sleep offset and is distributed throughout the sleep time as minutes of Stage N1 sleep, Stage N2 sleep, Stage N3, and rapid eye movement (REM) sleep. All these times are described in minutes.
A low total sleep time may indicate that the patient slept for an insufficient period of time due to non-medical/non-physiological reasons, certain medical or sleep disorders, or as a result of the effect of medications. Long total sleep time may suggest prior sleep deprivation, medical conditions, or effects of medications.
Measured: Baseline and month 6
Sleep Onset Latency (SOL) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Sleep Onset Latency (SOL) captured by Centrepoint Insight Actigraph watch:
Sleep latency is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch scored as sleep.
Sleep latency also indicates if reasonable attention was paid to the patient's sleep diary and the 'lights out' time was close to the patient's routine bedtime at home. Clearly, if the lights are turned out earlier than the patient's usual bedtime, sleep latency would be spuriously long, and the patient may not fall asleep until his/her usual sleep time is reached. Similarly, if the 'lights out' time is later than the patient's usual bedtime, the patient will be sleepy and a spuriously short sleep latency will be recorded. It is of utmost importance that the patient's usual habitual sleep time is incorporated into the patient's sleep study design and 'lights out' time is approximated.
Measured: Baseline and month 6
Sleep Efficiency (SE) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Sleep Efficiency (SE) captured by Centrepoint Insight Actigraph watch:
Sleep efficiency refers to percentage of total time in bed actually spent in sleep calculated as sum of Stage N1, Stage N2, Stage N3, and REM sleep, divided by the total time in bed and multiplied by 100.
Sleep efficiency gives an overall sense of how well the patient slept, but it does not distinguish frequent, brief episodes of wakefulness. A low sleep efficiency percentage could result from long sleep latency and long sleep offset to lights on time with otherwise normal quantity and quality of sleep in between. Many laboratories report total wake time, that is, the amount of wake time during the total recording time in minutes after the sleep onset. The total amount gives a general estimation for overall quality of sleep. Total wake time is the reciprocal of total sleep time. A high total sleep time percent is always associated with low total wake time percent and vice versa
Measured: Baseline and month 6
Wake After Sleep Onset (WASO) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Change in Wake After Sleep Onset (WASO) captured by Centrepoint Insight Actigraph watch:
Wake after sleep onset, also known as 'WASO' refers to periods of wakefulness occurring after defined sleep onset. This parameter measures wakefulness, excluding the wakefulness occurring before sleep onset. WASO time is a better reflection of sleep fragmentation.
Measured: Baseline and month 6
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function Aim 2.1
Change in PROMIS Short Form v2.0 - Physical Function score
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. The PROMIS short form v2.0 Physical function instrument is consists of 22 questions, each question has five response options ranging in value from one to five. The lowest possible raw score is 22 and the highest possible raw score is 113.
PROMIS instruments are scored using item-level calibrations. Scoring method uses responses to each item for each participant, referred to as "response pattern scoring." Tables showing score conversion are available in the PROMIS manual. Use the applicable table to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured.
Measured: Baseline to month 6 visit
Patient Global Impression of Change Aim 2.1
Change in Patient Global Impression of Change score
The Patient Global Impression of Change scale is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time. It is a patient-reported outcome measure that can be used to assess treatment benefit in clinical trials or practice. It is based on the Clinical Global Impression of Change scale, which is an observer-rated scale of symptom severity and treatment response. The scale ranges from 1 (no change or worse) to 7 (a great deal better).
Measured: Baseline to month 6 visit
California Verbal Learning Test (CVLT) Aim 2.1
The California Verbal Learning Test - Third Edition (CVLT-III) is a comprehensive assessment of verbal learning and memory. It produces a variety of scores, including:
d' score A raw score that reflects the difference between the hit rate (signal) and the false positive (FP) rate (noise). The d' score is calculated by subtracting the FP rate from the hit rate, after applying a z-transform to each.
Total RD A score that can range from +4.0 to -4.0. A high score indicates a high number of hits and a low number of FP errors, while a low score indicates a low number of hits and a high number of FP errors.
Scaled scores Scores that are adjusted for age and gender using the CVLT-3 standardization sample norms.
T-scores Scores that are derived from scaled scores and demographic information using look-up tables. T-scores are a comparison of an individual's memory performance to what is expected based on their demographics.
Measured: Baseline to month 6 visit
Grey matter volumes of the cingulate cortex and other prefrontal cortex regions Aim 2.2
Change in the structural brain MRI baseline grey matter volumes of the cingulate cortex and other prefrontal cortex regions at 6 months.
The investigators will use linear mixed effect and coefficient measures, and include sex, age, opioid medications, and duration of CP as confounders and as effect modifiers. Investigators will also estimate linear and non-linear trajectories.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start23 Oct 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evon Medics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Howard University, Global Pain Management, LLC, Georgetown University, University of Maryland, Johns Hopkins University, Family and Medical Counseling Service, Inc
- Responsible party
- Sponsor
- Investigators
- Charles Nwaokobia, Principal investigator, Evon Medics LLCEvaristus Nwulia, MD, MHS, Principal investigator, Evon Medics LLCTanya Alim, MD, Principal investigator, Howard UniversityHaddi Ogunsola, MD, Principal investigator, Global Pain Management, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671132
- Sponsor's protocol ID
- CBOTP2NS125745
- Other IDs
- 4R44NS125745-02
- Acronym
- CBOT-P-2
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-Pain) Testing Phase
- ClinicalTrials.gov ID
- NCT06671132
- Acronym / sponsor ID
- CBOT-P-2 / CBOTP2NS125745
- Conditions
- Chronic Pain, Low Back Pain
- Keywords
- Chronic pain, Pain, Negative Affect, Cognitive Impairments, Attenuation of Structural Brain Loss in CP with high NA, PACS outcome, Orbitofrontal Cortex, Chemosensory-Based Orbitofrontal Networks Training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Evon Medics LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Howard University, Global Pain Management, LLC, Georgetown University, University of Maryland, Johns Hopkins University, Family and Medical Counseling Service, Inc
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of this study phase, Phase II component is to perform a randomized clinical trial of the refined Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain [CBOT-Pain (or CBOT-P)] from Phase I, compared to sham Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) in Chronic Low Back Pain (CLBP) to determine its short- and long-term effectiveness on Pain, Negative Affect (NA), Cognition and Cortical Brain Structure (PACS), long-term safety, and indications.
The investigators will perform a randomized clinical trial of the refined CBOT-P from Phase I, compared to sham CBOT in CLBP.
Aim 2.1: To determine if CBOT-P significantly influences: (1) acute and long-term reduction of pain severity, and (2) acute and long-term reduction of negative affect. The hypothesis is that optimized CBOT will produce faster, stronger, and longer-lasting improvements in pain severity, NA severity, cognitive impairments, and sleep and functional outcomes.
Aim 2.2 To determine if CBOT-P significantly prevents or reduces progressive shrinkage in the orbitofrontal cortex (OFC), cingulate cortex, and hippocampus. MRI will be acquired at baseline and 6th month. An integrative analysis will be conducted to determine the link between changes in brain structure and cognitive trajectory. The hypothesis is that the CBOT optimized with BCP significantly attenuates shrinkage in OFC and other prefrontal cortex (PFC) regions, compared to the Sham intervention.
Detailed description
The Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P) is a project to develop an effective, scalable, user-friendly, and home-based neuromodulatory platform for broad-spectrum treatment of chronic pain conditions with associated negative affect and cognitive impairments.
The small business, Evon Medics created the olfactory pulsing technology called Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT-P) to enable home-based modulation of the OFC and subcortical limbic structures to treat pain and negative affect. In a stakeholder value canvassing exercise chronic pain (CP) sufferers and pain doctors unanimously desire new non-invasive, home-based, safe, and effective interventions that can reduce pain severity by more than 10%, suggesting that current treatments have limitations. Anterograde and retrograde anatomical tracings have been used to demonstrate direct (monosynaptic) anatomical connection between the OFC and the descending inhibitory pain nodes at the midbrain periaqueductal gray matter (PAG). Transition to CP is marked by weakened modulation of the PAG descending inhibition.
In this study phase, Phase II of this Fast-Track SBIR application, the investigators will conduct a multi-site study of 220 adult patients with CLBP to establish stronger evidence that the product controls pain, reduces negative mood, improves cognition, and protects the brain from shrinking in six months of treatment. Participants in this phase will be randomly assigned in a 1:1 ratio to daily treatment with CBOT-P device (i.e., CBOT with beta-caryophyllene (BCP) compared to a control (Sham) device that looks like the device but does not have the active ingredients and the programmed parameters on the ability to improve pain, mood, cognition and brain functions in chronic pain. Structural magnetic resonance imaging (MRI) will be acquired at baseline and after 6 months of daily treatment with optimized CBOT (based on Phase I) or Sham CBOT device to improve masking. Pain and NA measures, Cognitive batteries, and physical and functional measures will be assessed at baseline, months 1, 3, and 6. Participants would be encouraged through mobile health prompts to complete subjective pain, affect, sleep, and functional studies at the end of each study week. CLBP volunteers, radiologists, and clinicians assessing outcome measures will be blinded to these assignments.
The investigators will also collect user experiences to help refine a final marketable CBOT product, enter the FDA breakthrough designation program for pain that would lead to Medicare/Medicaid reimbursement, engage a wider network of pain stakeholders, and establish marketing for commercial success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBOT-P [CBOT + beta caryophyllene (BCP)] | Experimental | Combination Product: Computerized Chemosensory-Based Orbitofrontal Cortex Training for PainCBOT device with BCP |
| Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) | Sham comparator | Combination Product: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)CBOT device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18-85.
- Pain duration > 6 months.
- Must meet the minimum criteria for cognitive function using the PROMIS 4-item cognitive screener >3.
- Average pain score of > 5/10, with low back pain being the primary pain site. (5) CLBP (chronic low back pain) meeting Quebec Task Force Classification System Categories I-III.
- Evidence of a prior lumbar spine X-ray to rule out red flags, such as infection, tumor, or fracture.
Key exclusion criteria (10 listed)
- Back surgery within the past six months.
- Active worker's compensation or litigation claims.
- New pain and/or psychiatric treatments within 2 weeks of enrollment.
- Intent to add new or increase pain treatments during the study period, such as back surgery, nerve block procedures, or medications.
- Intent to add new psychiatric treatments during the first 3 months of the study.
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 |
|---|---|---|
| Computerized Chemosensory-Based Orbitofrontal Cortex Training for PainAlso: CBOT-P, CBOT device with BCPCBOT device with beta-caryophyllene | Combination product | CBOT-P [CBOT + beta caryophyllene (BCP)] |
| Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)Also: CBOT deviceCBOT device administering continuous olfactoy stimuli with no BCP | Combination product | Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) |
Primary outcome
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1)
Time frame: Baseline to month 1 visit
Change in 11-point score PROMIS Numeric Rating Scale v1.0 - Pain Intensity from baseline. The Numeric Rating Scale measures each consist of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain).
Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1)
Time frame: Baseline to month 1 visit
Change in negative affect score from the PANAS rating scale It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1)
Time frame: Baseline to month 3 visit
Change in 11-point score PROMIS Numeric Rating Scale v1.0 - Pain Intensity from baseline. The Numeric Rating Scale measures each consist of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain).
Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1)
Time frame: Baseline to month 3 visit
Change in negative affect score from the PANAS rating scale It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1)
Time frame: Baseline to month 6 visit
Change in 11-point score PROMIS Numeric Rating Scale v1.0 - Pain Intensity from baseline. The Numeric Rating Scale measures each consist of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain).
Positive and Negative Affect Schedule (PANAS) rating scale (Aim 2.1)
Time frame: Baseline to month 6 visit
Change in negative affect score from the PANAS rating scale It consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). Positive Affect Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.
Grey Matter Volumes of OrbitoFrontal Cortex and Hippocampus Aim 2.2
Time frame: Baseline and 6 months
Change in the structural brain MRI baseline grey matter volumes of the orbitofrontal cortex and hippocampus at 6 months. The investigators will use linear mixed effect and coefficient measures, and include sex, age, opioid medications, and duration of CP as confounders and as effect modifiers. Investigators will also estimate linear and non-linear trajectories.
31 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference scores. Aim 2.1
Time frame: Baseline to month 1 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 2.1
Time frame: Baseline to month 1 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 2.1
Time frame: Baseline to month 1 visit
Total Sleep Time (TST) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and 1 month
Sleep Onset Latency (SOL) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and 1 month
Sleep Efficiency (SE) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and 1 month
Wake After Sleep Onset (WASO) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and 1 month
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function Aim 2.1
Time frame: Baseline to month 1 visit
Patient Global Impression of Change Aim 2.1
Time frame: Baseline to month 1 visit
California Verbal Learning Test (CVLT) Aim 2.1
Time frame: Baseline to month 1 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference scores. Aim 2.1
Time frame: Baseline to month 3 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 2.1
Time frame: Baseline to month 3 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 2.1
Time frame: Baseline to month 3 visit
Total Sleep Time (TST) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and month 3
Sleep Onset Latency (SOL) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and month 3
Sleep Efficiency (SE) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and month 3
Wake After Sleep Onset (WASO) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and month 3
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function Aim 2.1
Time frame: Baseline to month 3 visit
Patient Global Impression of Change Aim 2.1
Time frame: Baseline to month 3 visit
California Verbal Learning Test (CVLT) Aim 2.1
Time frame: Baseline to month 3 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference scores. Aim 2.1
Time frame: Baseline to month 6 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 2.1
Time frame: Baseline to month 6 visit
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 2.1
Time frame: Baseline to month 6 visit
Total Sleep Time (TST) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and month 6
Sleep Onset Latency (SOL) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and month 6
Sleep Efficiency (SE) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and month 6
Wake After Sleep Onset (WASO) Centrepoint Insight Actigraph watch Sleep Parameters Aim 2.1
Time frame: Baseline and month 6
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function Aim 2.1
Time frame: Baseline to month 6 visit
Patient Global Impression of Change Aim 2.1
Time frame: Baseline to month 6 visit
California Verbal Learning Test (CVLT) Aim 2.1
Time frame: Baseline to month 6 visit
Grey matter volumes of the cingulate cortex and other prefrontal cortex regions Aim 2.2
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Charles Nwaokobia principal investigator
Evon Medics LLC
Evaristus Nwulia, MD, MHS principal investigator
Evon Medics LLC
Tanya Alim, MD principal investigator
Howard University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computerized Chemosensory-Based Orbitofrontal Cortex Training for Pain and Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) in people with Chronic Pain and Low Back Pain, run by Evon Medics LLC at 2 sites 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evaristus Nwulia, M.D., MHS (410-227-2005, enwulia@evonmedics.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity (Aim 2.1) (time frame: Baseline to month 1 visit). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2024.