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.

开始日期2024-10-23

申办/合作机构

Evon Medics LLC

[+7]

NCT06434818 / Recruiting临床2期

Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)

The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual (TAU) and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) device as active control. The investigators will conduct a multi-site study of 300 adult patients with opiate use disorder (OUD), stimulant (i.e., cocaine, methamphetamine) and/or alcohol use disorder (AUD) from community and clinics to evaluate whether EDITOR is associated with better patient treatment outcomes (e.g., retention in treatment and abstinence). The pilot study will provide preliminary data needed for design of a Phase III trial, including estimates of effect size. The investigators will also explore development of machine learning/AI algorithms integrating clinical and physiological data into treatment decision guides for providers.

开始日期2023-07-07

申办/合作机构

Evon Medics LLC

[+3]

NCT06218407 / Completed临床1期

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.

开始日期2023-04-27

申办/合作机构

Evon Medics LLC

[+3]

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0 项与 Evon Medics LLC 相关的专利（医药）

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项与 Evon Medics LLC 相关的文献（医药）

Neuropsychiatric disease and treatment4区 · 医学

Comparative Effects of Repetitive Odor Identification and Odor Memory Tasks on Olfactory Engagement in Older Populations – A Pilot fMRI Study

4区 · 医学

ArticleOA

作者: Shelby, Myeshia ; Nwaokobia, Charles ; Seth, Riya ; Nwulia, Evaristus ; Obisesan, Thomas O ; Adenuga, Ayokunnumi ; Misiak-Christian, Magdalena ; Manaye, Kebreten F ; VanMeter, John W ; Rai, Narayan ; Hipolito, Maria Mananita

OBJECTIVE:

This study evaluated human Blood Oxygen Level-Dependent (BOLD) responses in primary and higher-order olfactory regions of older adults, using odor memory and odor identification tasks. The goal was to determine which olfactory and memory regions of interest are more strongly engaged in older populations comparing these two odor training tasks.

METHODS:

Twelve adults 55-75 years old (75% females) without intranasal or major neurological disorders performed repetitive odor memory and identification tasks using a 3-tesla magnetic resonance scanner. Odors were presented intermittently at 10-second bursts separated by 20-second intervals of odorless air. Paired t-tests were used to compare differences in the degree of activation between odor identification and odor memory tasks within individuals. An FDR cluster-level correction of p<0.05 was used for multiplicity of tests (with a cluster-defining threshold set at p<0.01 and 10 voxels).

RESULTS:

Odor identification compared to memory (ie, odor identification > odor memory) contrasts had several areas of significant activation, including many of the classical olfactory brain regions as well as the hippocampus. The opposite contrast (odor memory > odor identification) included the piriform cortex, though this was not significant. Both tasks equally activated the piriform cortex, and thus when the two tasks are compared to each other this area of activation appears to be either absent (OI > OM) or only weakly observed (OM > OI).

CONCLUSION:

These findings from a predominantly African American sample suggest that odor identification tasks may be more potent than memory tasks in targeted olfactory engagement in older populations. Furthermore, repetitive odor identification significantly engaged the hippocampus - a region relevant to Alzheimer's disease - more significantly than did the odor memory task. If validated in larger studies, this result could have important implications in the design of olfactory training paradigms.

项与 Evon Medics LLC 相关的新闻（医药）

2023-09-21

·PRNewswire

Evon Medics TMS Group Transcranial Magnetic Stimulation (TMS) Therapy for Treatment Refractory Depression Now in Ellicott City

ELLICOTT CITY, Md., Sept. 21, 2023 /PRNewswire/ -- Evon Medics TMS Group is pleased to announce an expansion of our mental health services with the introduction of Transcranial Magnetic Stimulation (TMS) therapy as a promising treatment option for patients struggling with depression. Depression is a serious mental health condition affecting millions of individuals across the globe. While there are various treatment options available, not all patients respond to conventional therapies. This is why Evon Medics TMS Group is proud to offer TMS therapy as an innovative and effective alternative. TMS is a non-invasive, FDA-approved therapy that uses magnetic pulses to stimulate specific areas of the brain associated with depression. Clinical studies have shown significant improvement in depression symptoms for many patients who have undergone TMS therapy. As Evon Medics TMS Group continues to expand their services, the company welcomes referrals from their esteemed colleagues in the psychiatric community. If practitioners have patients who have not responded to traditional depression treatments or may benefit from TMS therapy, Evon Medics TMS Group is here to collaborate with them in providing comprehensive care. Benefits of Referring Patients to Evon Medics TMS Group: - Access to cutting-edge TMS therapy for treatment-resistant depression. - A highly experienced and compassionate team of psychiatrists and neurologists. - Coordinated care and seamless communication with referring psychiatrists. - Customized treatment plans using neurological principles tailored to each patient's unique needs. - Commitment to the highest standards of patient care and safety. To refer a patient or inquire about the TMS therapy program, please call 410-891-4012 or email [email protected]. Evon Medics TMS Group believes that together, a positive impact can be made on the lives of individuals living with depression. The company thanks the community for trusting in Evon Medics TMS Group as a partner in mental health care. For media inquiries or more information, please contact: Charles Nwaokobia [email protected] 410-891-4007 Ext 7 SOURCE Evon Medics TMS Group

2022-09-27

·BioSpace

Evon Medics, LLC Has Been Awarded $2.9 million Grant for the Evaluation of its Medical Device for the Treatment of Chronic Pain

ELLICOTT CITY, Md., Sept. 27, 2022 /PRNewswire/ -- Evon Medics, LLC today announced that it has been awarded a non-dilutive grant of $2.9 million for its FAST-TRACK SBIR (Small Business Innovation Research) study for the development and evaluation of its Computerized Chemosensory-Based Orbitofrontal Networks Training for Treatment of Pain (CBOT-P). This award is funded through the NIH HEAL (Helping to End Addiction Long-term) initiative and sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH). The CBOT-P is a portable, safe, and user-friendly device that uses chemosensory stimulation of the anatomical secondary olfactory cortex (part of the brain which plays a key role in pain and multisensory processing, pain control, decision making and emotion regulation) for home-based treatment of Chronic Pain. It works by using proprietary algorithms of stimulation parameters to trigger the neurons in the olfactory cortex with high fidelity. "This additional funding brings to total over $10 million of non-dilutive funding awarded to Evon Medics from 3 different institutes of the NIH in less than 4 years," said Charles Nwaokobia, Chief Operating Officer at Evon Medics. "This is further validation of the huge prospects of our unique and patented Olfactory Treatment Delivery Systems (OTDS) technology, which I believe is bound to disrupt the healthcare industry for management and treatment interventions of neurodegenerative and other neurological diseases in the near future." Evon Medics, LLC is a medical devices and neuroscience research company founded in April 2013 by Johns Hopkins trained physicians. The company develops therapeutics, diagnostics and devices for the treatment of Alzheimer's Disease, Opioid Use Disorder, Traumatic Brain Injury, Chronic pain, Treatment Refractory Depression, and other chronic neurological diseases that have remained elusive to treatment. The company Head Office is in Ellicott City, Maryland. Contact name: Charles Nwaokobia Email: 345395@email4pr.com Phone: 914-888-7678 Website:

2021-04-29

·BioSpace

Evon Medics, LLC Has Been Awarded $2.5 Million Grant for the Evaluation of its Medical Device for the Treatment of Alzheimer's Disease

ELKRIDGE, Md., April 29, 2021 /PRNewswire/ -- Small business, Evon Medics, LLC today announced that it has been awarded a non-dilutive grant of $2.5 million for its SBIR (Small Business Innovation Research) Phase II clinical trials for the development and evaluation of its non-invasive Computerized Olfactory Training (COT) medical device for home-based treatment of Alzheimer's Disease (AD). This funding is sponsored by the National Institute on Aging (NIA) of the National Institutes of Health (NIH). The COT is a portable, safe, and user-friendly device that uses chemosensory stimulation of the Primary Olfactory Cortex (part of the brain where neuropathology of AD begins) for the treatment of AD. It works by using proprietary stimulation parameters that overcome Olfactory Cortex desensitization and administering olfactory cognitive tasks that synergistically engage the Olfactory Cortex with high fidelity to increase its neuroplasticity and induce lasting positive changes in its functions. "This additional non-dilutive funding is yet another milestone achievement and a huge step towards our goal of getting our potentially disruptive and safe treatment to the millions of patients around the world suffering from Alzheimer's Disease," said Charles Nwaokobia, Chief Operating Officer at Evon Medics. "I believe the COT can effectively bridge the treatment gap and will be a delight to all Alzheimer's Disease patients who suffer from the numerous side effects of the currently available palliative treatments for AD. The pilot study showed very encouraging results and I am confident of similar results for the pivotal study we are about to embark on." Evon Medics, LLC is a medical devices and neuroscience research company founded in April 2013 by Johns Hopkins trained physicians. The company develops therapeutics and devices for the treatment of Alzheimer's Disease, Opioid Use Disorder, Traumatic Brain Injury, Chronic pain, Treatment Refractory Depression, and other chronic neurological diseases that have remained elusive to treatment. The company Head Office is in Elkridge, Maryland. Contact name: Charles Nwaokobia Email: 308639@email4pr.com Phone: 914-888-7678 Website:

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