Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P)
用于治疗疼痛的计算机化化学感应眼眶额网络训练 (CBOT-P) 的开发和评估
基本信息
- 批准号:10547925
- 负责人:
- 金额:$ 50万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-09-20 至 2023-08-31
- 项目状态:已结题
- 来源:
- 关键词:AcuteAcute PainAffectAffectiveAgonistAmericanAnalgesicsAnatomyAnimal ModelAnti-Inflammatory AgentsAnticonvulsantsAntidepressive AgentsAnxietyBehavior TherapyBeta-caryophylleneBrainBrain regionBusinessesCessation of lifeChronic low back painClinicalCognitionCognitiveCollaborationsCommunitiesDataDecision MakingDeep Brain StimulationDevelopmentDevicesDoseDrug AddictionEffectivenessElectric StimulationElectrodesEmotionsEndocannabinoidsEnrollmentEvaluationExerciseFeasibility StudiesFinancial HardshipFundingHomeHumanImpaired cognitionInterventionIntractable PainLateralLeadLong-Term EffectsManufacturer NameMarketingMeasuresMedialMedicare/MedicaidMental DepressionMidbrain structureMindfulness TrainingMoodsMotivationNarcoticsNational Institute of Drug AbuseNeuronal PlasticityNeurosciencesOlfactory CortexOperative Surgical ProceduresOpioid AnalgesicsOutcomePainPain ClinicsPain intensityPain managementPathologicPathway interactionsPatientsPersonsPhasePhysiologic pulsePhytochemicalPilot ProjectsPlayPopulationPrefrontal CortexPreventionProcessProviderPsychophysicsRandomizedRandomized Controlled TrialsRegimenRegulationResearchResearch PersonnelRewardsRoleSafetySeveritiesSiteSmall Business Innovation Research GrantStimulantStimulusStructureSubgroupTechnologyTestingTimeTrainingUniversitiesanatomical tracingattenuationbasechronic back painchronic painchronic pain managementchronic pain patientchronic painful conditioncognitive functioncombinatorialcomorbiditycomputerizedcost effectivedigitaldisabilitydrug relapseeffective interventioneffective therapyeffectiveness implementation studyefficacy studyemotion regulationexperiencefunctional lossgray matterhabituationimprovedinnovationinterestmidbrain central gray substancemultisensorynegative affectnerve damageneuromechanismneuroregulationnon-opioid analgesicopioid misuseopioid useopioid use disorderoverdose deathpain chronificationpain patientpain processingpain reductionpain reliefpain sensitivitypatient orientedpreventprogramsrandomized trialreceptorresponseside effectsuccesstreatment as usualtrenduser-friendly
项目摘要
PHASE I/II (FAST/TRACK) ABSTRACT
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. Chronic pain (CP) affects 1.5 billion people globally, and causes
severe human suffering, disability, and high financial burden. Clinical and neuroscience studies show that CP
over time leads to shrinkage in the prefrontal cortex (PFC) regions and their deep brain connections critical to
emotion, motivation, and cognitive functions. As a result, more than 40% of CP patients suffer negative affect
(i.e., anxiety and depression), cognitive and decision-making problems and reduced drive. Chronic pain with
negative affect (CP-N) is more debilitating, harder to treat, costlier to payers and significantly more associated
with opioid use, overdose, and deaths. 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. Evon Medics, a small
business specializing in olfactory neurotherapeutics, developed an innovative chemosensory-based
orbitofrontal cortex (OFC) stimulation device, called CBOT-P, for home use, to increase OFC plasticity and
effect OFC-induced regulation of pain and negative affect. We now plan to refine this product for broad pain
conditions and quickly make it available to the population. OFC is the part of the prefrontal cortex that plays
key roles in multisensory integration, affect regulation, and decision-making. The lateral OFC, which is
consistently activated by pain, is connected to other cortical brain regions that process pain; and the medial
OFC, which networks with medial temporal affect networks, is engaged by mindfulness therapy for pain and
plays important role in positive affect and drive. Unfortunately, CP and opioid analgesics are associated with
OFC shrinkage, which amplifies pain through increased negative affect (NA) and cognitive impairment. The
success of CBOT-P in acute relief of NA and pain in our pilot studies is not surprising because single-pulsed
electrical stimulations with OFC-placed electrodes acutely relieved NA in humans in invasive deep brain
stimulation, and experimentally induced stimulation of the OFC in animal models and humans activates the
PAG to reduce pain sensitization. The CBOT-P uses Evon’s proprietary regimen of 10 odorant phytochemicals
to stimulate the secondary olfactory cortex (i.e. the OFC) repetitively, with established micro-controller-
regulated stimulation parameter settings that maintain persistent activation of the OFC and medial temporal
regions, without habituation; paired with digitally-administered olfactory psychophysical training tasks that
activate same regions, for synergistic effect on long-term neuroplasticity changes that prevents CP-induced
shrinkage. As a second mechanism of action, the olfactory stimulants were fortified with proprietary
components, such as beta-caryophyllene (BCP), a selective endocannabinoid-2 receptor agonist, which has
strong anti-inflammatory and antinociceptive effects, and scalable for acute positive affect.
In the Phase I of this Fast-Track SBIR application, we 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. In Phase II, we will perform a
powered randomized trial of the refined CBOT-P from Phase I, compared to sham CBOT in CLBP, to
determine its short- and long-term effectiveness on Pain, Affect, Cognition and cortical brain Structure (PACS),
long-term safety, and indications. We 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. Project success will be enhanced through strong collaborations between Evon Medics, Johns
Hopkins (JHU) Pain Center, Howard University investigators, community pain providers and collaborating
manufacturers. To the best of our knowledge this will be the first home-based combinatorial digital-
chemosensory neuromodulatory product for stimulation of deep brain regions for CP management.
i / ii阶段(快速/跟踪)摘要
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Charles Chiedu Nwaokobia其他文献
Charles Chiedu Nwaokobia的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Charles Chiedu Nwaokobia', 18)}}的其他基金
Development and Evaluation of Portable Compendium of Psychophysical and Physiological Tests for Alzheimer's Disease and Related Dementias (ADRD)
阿尔茨海默病和相关痴呆症(ADRD)便携式心理物理和生理测试纲要的开发和评估
- 批准号:
10699349 - 财政年份:2023
- 资助金额:
$ 50万 - 项目类别:
The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
用于药物使用障碍远程管理的增强型数字化学感应嗅觉训练的开发和评估(编辑)
- 批准号:
10794665 - 财政年份:2023
- 资助金额:
$ 50万 - 项目类别:
The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
用于药物使用障碍远程管理的增强型数字化学感应嗅觉训练的开发和评估(编辑)
- 批准号:
10741580 - 财政年份:2022
- 资助金额:
$ 50万 - 项目类别:
The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
用于药物使用障碍远程管理的增强型数字化学感应嗅觉训练的开发和评估(编辑)
- 批准号:
10469912 - 财政年份:2022
- 资助金额:
$ 50万 - 项目类别:
Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)
针对早期阿尔茨海默病 (AD) 认知衰退的计算机嗅觉训练计划 (COT) 的开发和评估
- 批准号:
10574428 - 财政年份:2018
- 资助金额:
$ 50万 - 项目类别:
Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease
针对早期阿尔茨海默病认知衰退的计算机嗅觉训练计划 (COT) 的开发和评估
- 批准号:
10614897 - 财政年份:2018
- 资助金额:
$ 50万 - 项目类别:
Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)
针对早期阿尔茨海默病 (AD) 认知衰退的计算机嗅觉训练计划 (COT) 的开发和评估
- 批准号:
10399659 - 财政年份:2018
- 资助金额:
$ 50万 - 项目类别:
Development and Evaluation of Computerized Olfactory Training Program (COT) for Cognitive Decline in Early Alzheimer's Disease (AD)
针对早期阿尔茨海默病 (AD) 认知衰退的计算机嗅觉训练计划 (COT) 的开发和评估
- 批准号:
10256329 - 财政年份:2018
- 资助金额:
$ 50万 - 项目类别:
相似海外基金
Selective actin remodeling of sensory neurons for acute pain management
感觉神经元的选择性肌动蛋白重塑用于急性疼痛管理
- 批准号:
10603436 - 财政年份:2023
- 资助金额:
$ 50万 - 项目类别:
Clinical Outcome Assessments for Acute Pain Therapeutics in Infants and young Children (COA APTIC)
婴幼儿急性疼痛治疗的临床结果评估 (COA APTIC)
- 批准号:
10778757 - 财政年份:2023
- 资助金额:
$ 50万 - 项目类别:
Clinical Outcome Assessments for Acute Pain Therapeutics in Infants and young Children (COA APTIC)
婴幼儿急性疼痛治疗的临床结果评估 (COA APTIC)
- 批准号:
10783106 - 财政年份:2023
- 资助金额:
$ 50万 - 项目类别:
Development of A Focused Ultrasound Device for Noninvasive, Peripheral Nerve Blockade to Manage Acute Pain
开发用于非侵入性周围神经阻断来治疗急性疼痛的聚焦超声装置
- 批准号:
10740796 - 财政年份:2023
- 资助金额:
$ 50万 - 项目类别:
Predicting Pediatric Sickle Cell Disease Acute Pain Using Mathematical Models Based on mHealth Data
使用基于移动健康数据的数学模型预测儿童镰状细胞病急性疼痛
- 批准号:
10599401 - 财政年份:2022
- 资助金额:
$ 50万 - 项目类别:
Non-Contingent Acute Pain Stress Drives Analgesic Protection in Rats.
非偶然急性疼痛应激驱动大鼠镇痛保护。
- 批准号:
575854-2022 - 财政年份:2022
- 资助金额:
$ 50万 - 项目类别:
Alexander Graham Bell Canada Graduate Scholarships - Master's
Prefrontal Cortex Hemodynamic Responses to Mindfulness Meditation and Acute Pain
前额皮质血流动力学对正念冥想和急性疼痛的反应
- 批准号:
467076 - 财政年份:2021
- 资助金额:
$ 50万 - 项目类别:
Studentship Programs
A Multimodal Approach for Monitoring Prolonged Acute Pain in Neonates
监测新生儿长期急性疼痛的多模式方法
- 批准号:
9979265 - 财政年份:2020
- 资助金额:
$ 50万 - 项目类别:
A Multimodal Approach for Monitoring Prolonged Acute Pain in Neonates
监测新生儿长期急性疼痛的多模式方法
- 批准号:
10218273 - 财政年份:2020
- 资助金额:
$ 50万 - 项目类别: