Chronic PainPhase 1CBOT-PainNCT06218407
Development and Evaluation of Computerized Chemosensory Based Orbitofrontal Networks Training for Treatment of Pain
A Phase 1 study testing Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) short burst paradigm, Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long burst paradigm and Computerized Chemosensory-Based Orbitofrontal Cortex Training plus beta caryophyllene (CBOT-Plus) in people with Chronic Pain and Low Back Pain, run by Evon Medics LLC at 1 site in United States.
Trial summary
The overarching goal of this study phase, Phase I component is to configure Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) into Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain CBOT-Pain (or CBOT-P) for rapid and sustained reduction of Pain, Negative Affect… 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 (CBOT) short burst paradigm, Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long burst paradigm and Computerized Chemosensory-Based Orbitofrontal Cortex Training plus beta caryophyllene (CBOT-Plus)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2023to 15 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 2-item cognitive screener >3.
- Average pain score of > 5/10, with low back pain being the primary pain site.
- 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.
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- 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.
- Subject must agree that opioids cannot be increased during the study.
- No substance use disorder (SUD), except tobacco, in the past year based on substance screening surveys and frequent urine toxicology screens.
- No acute suicidality, mania, or psychosis. This will be assessed at study entry which will also include a review of history in the EHR, Structured Clinical Interview for Psychiatric Disorders (SCID-5) and Columbia Suicide Severity Rating Scale (C-SSRS) and -
- 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.
- Anosmia or significant nasal disease
- Contraindications to MRI
- Stroke or TBI (traumatic brain injury).
Trial locations and contacts
1 site in 1 country.
United States1 site
Howard University
Washington D.C., District of Columbia, 20060
About this study
Official title: Development and Evaluation of Computerized Chemosensory Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)
The overarching goal of this study phase, Phase I component is to configure Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) into Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain CBOT-Pain (or CBOT-P) for rapid and sustained reduction of Pain, Negative Affect (NA) and Cognitive Impairments. The investigators aimed at first establishing if stimulation parameters targeting key olfactory regions, and their associated networks, paired with tasks that synergistically activate the orbitofrontal cortex (OFC) would have significantly different acute (< 7 days) effects in pain and NA intensity reductions. The hypothesis is that the short burst paradigm will more effectively activate the medial OFC and its functional connectivity with medial temporal affective networks, and result in greater reduction of affect and pain severity ratings after 7 days. The investigators will further examine if enhancing the odor regimen with beta-caryophyllene (BCP) content would have more dramatic effects in acute relief of pain, NA, and cognition.
Aim 1.1: To optimize CBOT-P stimulation parameters and olfactory stimulants for pain, affect and cognition in CP with and without high NA. This is a 14-day prospective study, in which fMRI and rs-fMRI will be acquired at baseline and day 7 during exposure to short vs long-burst CBOT stimulations. This is followed by daily treatment with short-burst versus long-burst CBOT paradigm over 14 days, during which pain and NA measures will be recorded daily by the subjects, and assessed by train research staff at baseline, day 7 and day 14.
Aim 1.2: To determine if CBOT regimen optimized with BCP content produces stronger and faster pain and affective response. This is a 14-day prospective study design, in which daily treatment of CBOT-PLUS (i.e., CBOT with BCP) will be compared against daily treatment with CBOT without BCP enhancement (CBOT). Subjects and clinicians are blinded to the assigned arms. Pain and NA measures will be recorded daily by the subjects and assessed by trained research staff at baseline and day 14.
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 homebased 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 for treatment of pain and negative affect. In a stakeholder value canvassing exercise 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 I of this Fast-Track SBIR application, the investigators will (a) configure CBOT-P regimen and stimulation parameters for faster onset of mood elevating and analgesic effects, focusing on Chronic Low Back Pain populations and (b) establish its neural mechanism of action through target-engagement studies of OFC activity and functional connectivity with other pain regulating regions at baseline.
- Conditions
- Chronic Pain, Low Back Pain
- Being tested
- Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) short burst paradigm, Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long burst paradigm, Computerized Chemosensory-Based Orbitofrontal Cortex Training plus beta caryophyllene (CBOT-Plus), Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)
- Keywords
- Chronic Pain (CP), Pain, Negative Affect (NA), 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 (CBOT) short burst paradigmCombination product
Also called CBOT-Short
The CBOT device is designed to stimulate intensive neural activity in the medial orbitofrontal regions over long periods of time.
Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long burst paradigmCombination product
Also called CBOT-Long
The CBOT device is designed to stimulate intensive neural activity in the lateral orbitofrontal regions and networks over long periods of time.
Computerized Chemosensory-Based Orbitofrontal Cortex Training plus beta caryophyllene (CBOT-Plus)Combination product
Also called CBOT Plus
CBOT device enhanced with BCP.
Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)Combination product
Also called CBOT
CBOT device administering continuous olfactory stimuli (i.e., not programmed for short or long burst), and without BCP enhancement.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) short-burst paradigm | Experimental | CBOT consists of repetitive cycles of olfactory stimulation and tasks daily for 14 days. Receives: Combination Product: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) short burst paradigm |
| Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long-burst paradigm | Experimental | CBOT consists of repetitive cycles of olfactory stimulation and tasks daily for 14 days. Receives: Combination Product: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long burst paradigm |
| CBOT plus (CBOT + beta caryophyllene [BCP]) | Experimental | CBOT device enhanced with BCP Receives: Combination Product: Computerized Chemosensory-Based Orbitofrontal Cortex Training plus beta caryophyllene (CBOT-Plus) |
| Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) | Sham comparator | CBOT device without BCP enhancement as control for BCP 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.
Relative changes in blood oxygen level dependent (BOLD) signals from fMRI of orbitofrontal brain regions in response to short durations (i.e., short-bursts) and to long durations (i.e., long-bursts) of repetitive odor stimulations. Aim 1.1
The blood-oxygen-level-dependent (BOLD) signal, acquired in functional Magnetic Resonance Imaging (fMRI), is a reflection of changes in deoxyhemoglobin driven by localized changes in brain blood flow and blood oxygenation, which are coupled to underlying neuronal activity by a process termed neurovascular coupling. In the context of pain disorders, fMRI has been used to study changes in brain function related to pain and to responses to interventions for pain. In the context of this study, positive BOLD signals in the brain region of interest, seen in response to odorant stimuli, represent a decrease in deoxyhemoglobin and thus an over-oxygenation of the responding region. Studies have shown that these changes in BOLD signals correlate with brain activity - with positive increase in BOLD signal reflective of increased brain activity and decreased BOLD signal reflective of reduced brain activity.
Measured: Baseline
Changes in the resting-state functional connectivity between midbrain and corticolimbic brain regions Aim 1.1
Changes in the resting-state functional connectivity between midbrain and corticolimbic brain regions, defined as correlations between low-frequency oscillations in the functional magnetic resonance (fMRI) blood oxygenation level dependent signal in these brain regions of interest acquired in the absence of a cognitive task. As a correlation, this measure ranges from -1 to 1. The higher the value (above zero) between two brain regions the more positively correlated are their low-frequency oscillations of fMRI blood oxygenation level dependent signals. The lower their value (below zero) between brain regions the more negatively correlated are their low-frequency oscillations of fMRI blood oxygenation level dependent signals.
Measured: Baseline to day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity Aim 1.1
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 day 7
Positive and Negative Affect Schedule (PANAS) rating scale Aim 1.1
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 day 7
Relative changes in blood oxygen level dependent (BOLD) signals from fMRI of orbitofrontal brain regions in response to short durations (i.e., short-bursts) and to long durations (i.e., long-bursts) of repetitive odor stimulations. Aim 1.1
The blood-oxygen-level-dependent (BOLD) signal, acquired in fMRI, is a reflection of changes in deoxyhemoglobin driven by localized changes in brain blood flow and blood oxygenation, which are coupled to underlying neuronal activity by a process termed neurovascular coupling. In the context of pain disorders, fMRI has been used to study changes in brain function related to pain and to responses to interventions for pain. In the context of this study, positive BOLD signals in the brain region of interest, seen in response to odorant stimuli, represent a decrease in deoxyhemoglobin and thus an over-oxygenation of the responding region. Studies have shown that these changes in BOLD signals correlate with brain activity - with positive increase in BOLD signal reflective of increased brain activity and decreased BOLD signal reflective of reduced brain activity.
Measured: 7 days after baseline
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity Aim 1.2
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 day 7
Positive and Negative Affect Schedule (PANAS) rating scale Aim 1.2
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 day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity Aim 1.1
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 day 14
Positive and Negative Affect Schedule (PANAS) rating scale Aim 1.1
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 day 14
Changes in the resting-state functional connectivity between midbrain and corticolimbic brain regions Aim 1.1
Changes in the resting-state functional connectivity between midbrain and corticolimbic brain regions, defined as correlations between low-frequency oscillations in the functional magnetic resonance (fMRI) blood oxygenation level dependent signal in these brain regions of interest acquired in the absence of a cognitive task. As a correlation, this measure ranges from -1 to 1. The higher the value (above zero) between two brain regions the more positively correlated are their low-frequency oscillations of fMRI blood oxygenation level dependent signals. The lower their value (below zero) between brain regions the more negatively correlated are their low-frequency oscillations of fMRI blood oxygenation level dependent signals.
Measured: Baseline to 14
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity Aim 1.2
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 day 14
Positive and Negative Affect Schedule (PANAS) rating scale Aim 1.2
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 day 14
Secondary outcomes (18)
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference scores. Aim 1.1
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 day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 1.1
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 day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 1.1
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 day 7
Pittsburgh Sleep Quality Index (PSQI) Aim 1.1
Change in Pittsburgh Sleep Quality Index (PSQI) scores
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. Each component generates a score from 0-3 where higher scores indicate poorer sleep outcomes.
In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
A global score above 5 indicates poor sleep quality.
Measured: Baseline to day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 1.2
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 day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 1.2
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 day 7
Pittsburgh Sleep Quality Index (PSQI) Aim 1.2
Change in Pittsburgh Sleep Quality Index (PSQI) scores
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. Each component generates a score from 0-3 where higher scores indicate poorer sleep outcomes.
In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
A global score above 5 indicates poor sleep quality.
Measured: Baseline to day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function Aim 1.2
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 day 7
Patient Global Impression of Change Aim 1.2
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 day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference scores. Aim 1.1
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 day 14
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 1.1
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 day 14
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 1.1
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 day 14
Pittsburgh Sleep Quality Index (PSQI) Aim 1.1
Change in Pittsburgh Sleep Quality Index (PSQI) scores
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. Each component generates a score from 0-3 where higher scores indicate poorer sleep outcomes.
In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
A global score above 5 indicates poor sleep quality.
Measured: Baseline to day 14
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 1.2
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 day 14
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 1.2
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 day 14
Pittsburgh Sleep Quality Index (PSQI) Aim 1.2
Change in Pittsburgh Sleep Quality Index (PSQI) scores
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. Each component generates a score from 0-3 where higher scores indicate poorer sleep outcomes.
In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.
A global score above 5 indicates poor sleep quality.
Measured: Baseline to day 14
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function Aim 1.2
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 day 14
Patient Global Impression of Change Aim 1.2
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 day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start27 Apr 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
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, Georgetown University
- Responsible party
- Sponsor
- Investigators
- Charles Nwaokobia, Principal investigator, Evon Medics LLCEvaristus Nwulia, MD, Principal investigator, Howard UniversityTanya Alim, MD, Principal investigator, Howar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218407
- Sponsor's protocol ID
- CBOTNS125745
- Other IDs
- 1R44NS125745-01A1
- Acronym
- CBOT-Pain
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 23 Jan 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 23 Jan 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-P)
- ClinicalTrials.gov ID
- NCT06218407
- Acronym / sponsor ID
- CBOT-Pain / CBOTNS125745
- Conditions
- Chronic Pain, Low Back Pain
- Keywords
- Chronic Pain (CP), Pain, Negative Affect (NA), Cognitive Impairments, Attenuation of Structural Brain loss in CP with high NA, PACS outcome, Orbitofrontal cortex, Chemosensory-Based Orbitofrontal Networks Training
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Evon Medics LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Howard University, Georgetown University
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 23 Jan 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 I component is to configure Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) into Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain CBOT-Pain (or CBOT-P) for rapid and sustained reduction of Pain, Negative Affect (NA) and Cognitive Impairments. The investigators aimed at first establishing if stimulation parameters targeting key olfactory regions, and their associated networks, paired with tasks that synergistically activate the orbitofrontal cortex (OFC) would have significantly different acute (< 7 days) effects in pain and NA intensity reductions. The hypothesis is that the short burst paradigm will more effectively activate the medial OFC and its functional connectivity with medial temporal affective networks, and result in greater reduction of affect and pain severity ratings after 7 days. The investigators will further examine if enhancing the odor regimen with beta-caryophyllene (BCP) content would have more dramatic effects in acute relief of pain, NA, and cognition.
Aim 1.1: To optimize CBOT-P stimulation parameters and olfactory stimulants for pain, affect and cognition in CP with and without high NA. This is a 14-day prospective study, in which fMRI and rs-fMRI will be acquired at baseline and day 7 during exposure to short vs long-burst CBOT stimulations. This is followed by daily treatment with short-burst versus long-burst CBOT paradigm over 14 days, during which pain and NA measures will be recorded daily by the subjects, and assessed by train research staff at baseline, day 7 and day 14.
Aim 1.2: To determine if CBOT regimen optimized with BCP content produces stronger and faster pain and affective response. This is a 14-day prospective study design, in which daily treatment of CBOT-PLUS (i.e., CBOT with BCP) will be compared against daily treatment with CBOT without BCP enhancement (CBOT). Subjects and clinicians are blinded to the assigned arms. Pain and NA measures will be recorded daily by the subjects and assessed by trained research staff at baseline and day 14.
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 homebased 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 for treatment of pain and negative affect. In a stakeholder value canvassing exercise 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 I of this Fast-Track SBIR application, the investigators will (a) configure CBOT-P regimen and stimulation parameters for faster onset of mood elevating and analgesic effects, focusing on Chronic Low Back Pain populations and (b) establish its neural mechanism of action through target-engagement studies of OFC activity and functional connectivity with other pain regulating regions at baseline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) short-burst paradigm | Experimental | Combination Product: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) short burst paradigmCBOT consists of repetitive cycles of olfactory stimulation and tasks daily for 14 days. |
| Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long-burst paradigm | Experimental | Combination Product: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long burst paradigmCBOT consists of repetitive cycles of olfactory stimulation and tasks daily for 14 days. |
| CBOT plus (CBOT + beta caryophyllene [BCP]) | Experimental | Combination Product: Computerized Chemosensory-Based Orbitofrontal Cortex Training plus beta caryophyllene (CBOT-Plus)CBOT device enhanced with BCP |
| Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) | Sham comparator | Combination Product: Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)CBOT device without BCP enhancement as control for BCP |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ages 18-85.
- Pain duration > 6 months.
- Must meet the minimum criteria for cognitive function using the PROMIS 2-item cognitive screener >3.
- Average pain score of > 5/10, with low back pain being the primary pain site.
- CLBP (chronic low back pain) meeting Quebec Task Force Classification System Categories I-III.
Key exclusion criteria (12 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 (CBOT) short burst paradigmAlso: CBOT-ShortThe CBOT device is designed to stimulate intensive neural activity in the medial orbitofrontal regions over long periods of time. | Combination product | Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) short-burst paradigm |
| Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long burst paradigmAlso: CBOT-LongThe CBOT device is designed to stimulate intensive neural activity in the lateral orbitofrontal regions and networks over long periods of time. | Combination product | Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long-burst paradigm |
| Computerized Chemosensory-Based Orbitofrontal Cortex Training plus beta caryophyllene (CBOT-Plus)Also: CBOT PlusCBOT device enhanced with BCP. | Combination product | CBOT plus (CBOT + beta caryophyllene [BCP]) |
| Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)Also: CBOTCBOT device administering continuous olfactory stimuli (i.e., not programmed for short or long burst), and without BCP enhancement. | Combination product | Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) |
Primary outcome
Relative changes in blood oxygen level dependent (BOLD) signals from fMRI of orbitofrontal brain regions in response to short durations (i.e., short-bursts) and to long durations (i.e., long-bursts) of repetitive odor stimulations. Aim 1.1
Time frame: Baseline
The blood-oxygen-level-dependent (BOLD) signal, acquired in functional Magnetic Resonance Imaging (fMRI), is a reflection of changes in deoxyhemoglobin driven by localized changes in brain blood flow and blood oxygenation, which are coupled to underlying neuronal activity by a process termed neurovascular coupling. In the context of pain disorders, fMRI has been used to study changes in brain function related to pain and to responses to interventions for pain. In the context of this study, positive BOLD signals in the brain region of interest, seen in response to odorant stimuli, represent a decrease in deoxyhemoglobin and thus an over-oxygenation of the responding region. Studies have shown that these changes in BOLD signals correlate with brain activity - with positive increase in BOLD signal reflective of increased brain activity and decreased BOLD signal reflective of reduced brain activity.
Changes in the resting-state functional connectivity between midbrain and corticolimbic brain regions Aim 1.1
Time frame: Baseline to day 7
Changes in the resting-state functional connectivity between midbrain and corticolimbic brain regions, defined as correlations between low-frequency oscillations in the functional magnetic resonance (fMRI) blood oxygenation level dependent signal in these brain regions of interest acquired in the absence of a cognitive task. As a correlation, this measure ranges from -1 to 1. The higher the value (above zero) between two brain regions the more positively correlated are their low-frequency oscillations of fMRI blood oxygenation level dependent signals. The lower their value (below zero) between brain regions the more negatively correlated are their low-frequency oscillations of fMRI blood oxygenation level dependent signals.
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity Aim 1.1
Time frame: Baseline to day 7
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 1.1
Time frame: Baseline to day 7
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.
Relative changes in blood oxygen level dependent (BOLD) signals from fMRI of orbitofrontal brain regions in response to short durations (i.e., short-bursts) and to long durations (i.e., long-bursts) of repetitive odor stimulations. Aim 1.1
Time frame: 7 days after baseline
The blood-oxygen-level-dependent (BOLD) signal, acquired in fMRI, is a reflection of changes in deoxyhemoglobin driven by localized changes in brain blood flow and blood oxygenation, which are coupled to underlying neuronal activity by a process termed neurovascular coupling. In the context of pain disorders, fMRI has been used to study changes in brain function related to pain and to responses to interventions for pain. In the context of this study, positive BOLD signals in the brain region of interest, seen in response to odorant stimuli, represent a decrease in deoxyhemoglobin and thus an over-oxygenation of the responding region. Studies have shown that these changes in BOLD signals correlate with brain activity - with positive increase in BOLD signal reflective of increased brain activity and decreased BOLD signal reflective of reduced brain activity.
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity Aim 1.2
Time frame: Baseline to day 7
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 1.2
Time frame: Baseline to day 7
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 1.1
Time frame: Baseline to day 14
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 1.1
Time frame: Baseline to day 14
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.
Changes in the resting-state functional connectivity between midbrain and corticolimbic brain regions Aim 1.1
Time frame: Baseline to 14
Changes in the resting-state functional connectivity between midbrain and corticolimbic brain regions, defined as correlations between low-frequency oscillations in the functional magnetic resonance (fMRI) blood oxygenation level dependent signal in these brain regions of interest acquired in the absence of a cognitive task. As a correlation, this measure ranges from -1 to 1. The higher the value (above zero) between two brain regions the more positively correlated are their low-frequency oscillations of fMRI blood oxygenation level dependent signals. The lower their value (below zero) between brain regions the more negatively correlated are their low-frequency oscillations of fMRI blood oxygenation level dependent signals.
Patient Reported Outcomes Measurement Information System (PROMIS) Numeric Rating Scale v1.0 - Pain Intensity Aim 1.2
Time frame: Baseline to day 14
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 1.2
Time frame: Baseline to day 14
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.
18 secondary outcomes
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference scores. Aim 1.1
Time frame: Baseline to day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 1.1
Time frame: Baseline to day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 1.1
Time frame: Baseline to day 7
Pittsburgh Sleep Quality Index (PSQI) Aim 1.1
Time frame: Baseline to day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 1.2
Time frame: Baseline to day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 1.2
Time frame: Baseline to day 7
Pittsburgh Sleep Quality Index (PSQI) Aim 1.2
Time frame: Baseline to day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function Aim 1.2
Time frame: Baseline to day 7
Patient Global Impression of Change Aim 1.2
Time frame: Baseline to day 7
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.1 - Pain Interference scores. Aim 1.1
Time frame: Baseline to day 14
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 1.1
Time frame: Baseline to day 14
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 1.1
Time frame: Baseline to day 14
Pittsburgh Sleep Quality Index (PSQI) Aim 1.1
Time frame: Baseline to day 14
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Anxiety scores Aim 1.2
Time frame: Baseline to day 14
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Sleep Disturbance scores Aim 1.2
Time frame: Baseline to day 14
Pittsburgh Sleep Quality Index (PSQI) Aim 1.2
Time frame: Baseline to day 14
Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 - Physical Function Aim 1.2
Time frame: baseline to day 14
Patient Global Impression of Change Aim 1.2
Time frame: Baseline to day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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. This study is not recruiting at the moment.
Charles Nwaokobia principal investigator
Evon Medics LLC
Evaristus Nwulia, MD principal investigator
Howard University
Tanya Alim, MD principal investigator
Howar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) short burst paradigm, Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) long burst paradigm and Computerized Chemosensory-Based Orbitofrontal Cortex Training plus beta caryophyllene (CBOT-Plus) in people with Chronic Pain and Low Back Pain, run by Evon Medics LLC at 1 site 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 11 inclusion and 12 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: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative changes in blood oxygen level dependent (BOLD) signals from fMRI of orbitofrontal brain regions in response to short durations (i.e., short-bursts) and to long durations (i.e., long-bursts) of repetitive odor stimulations. Aim 1.1 (time frame: Baseline). The study lists 12 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 23 Jan 2024.