Development and Evaluation of Computerized Chemosensory Based Orbitofrontal Networks Training for Treatment of Pain

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 (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.

Conditions

• Chronic Pain
• Low Back Pain

Interventions

COMBINATION_PRODUCT

Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) short burst paradigm

The 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) long burst paradigm

The 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 plus beta caryophyllene (CBOT-Plus)

CBOT device enhanced with BCP.

COMBINATION_PRODUCT

Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT)

CBOT device administering continuous olfactory stimuli (i.e., not programmed for short or long burst), and without BCP enhancement.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Howard University

  collaborator OTHER

• Georgetown University

  collaborator OTHER

• Evon Medics LLC

  lead INDUSTRY

Principal Investigators

• Charles Nwaokobia · Evon Medics LLC

• Evaristus Nwulia, MD · Howard University

• Tanya Alim, MD · Howar

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-27

Primary Completion

2023-09-15

Completion

2023-09-15

FDA Drug

Yes

Countries

• United States

Study Locations