Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain

Study Purpose

The purpose of this study is to investigate, in two phases:

(1) the feasibility and safety of Virtual Embodiment Therapy in treating chronic pain of lower back and upper limbs and (2) the efficacy of Virtual Embodiment Therapy on chronic pain disorders of the lower back and upper limbs.

In phase 1, we will investigate the feasibility, safety, and side effects related to this treatment by assessing simulator sickness. In phase 2, which in contingent on successful completion of phase 1, we will assess symptoms of pain specific to the region treated, fear and avoidance behavior, and depression symptoms before and after 8 sessions of treatment with Virtual Embodiment Therapy in order to assess efficacy. This study will be single-blinded, because the participation of the clinician is necessary to ensure proper administration of the therapy, as well as to monitor in the event of adverse reactions.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Able to understand the English language. 2. Have had a chronic central pain of the lower back or upper limbs diagnosis for 3 months or longer. 3. Can attend sessions at the study center twice a week for 4 weeks. 4. Able to wear a VR HMD (head-mounted display) and move head in cervical rotation, extension, and flexion.

Exclusion Criteria:

1. Individuals with a history of Severe Mental Illness, including schizophrenia, bipolar disorder I or II, or PTSD. 2. History of susceptibility to seizures per subject's reporting. 3. Pregnant woman

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04060875
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Karuna Labs Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Michael Trujillo, PhD
Principal Investigator Affiliation	Vice President of Clinical Affairs
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Pain, Low Back Pain, Fibromyalgia, Upper Extremity Dysfunction, Complex Regional Pain Syndromes, Phantom Limb Pain, Rheumatoid Arthritis, Carpal Tunnel Syndrome, Repetitive Strain Injury

Additional Details

This multi-site study aims to investigate the feasibility, safety, and efficacy of using embodied virtual reality graded motor imagery software to treat adults with diagnosed chronic central pain conditions in two bodily regions: chronic pain in the lower back and in the upper limbs. The research will be conducted in two phases, the second of which is contingent upon successful completion of the first. The first phase will involve piloting a novel virtual reality treatment for chronic pain to investigate feasibility and safety with a smaller number of patients (N=30 for each condition). The second phase of the research will investigate efficacy using a single-blinded randomized control study design with sham control. Chronic pain conditions of the lower back and upper limbs will be investigated separately, and power analyses have been conducted to determine optimal study size, which is N=200 for each portion. Central pain is defined as pain that originates in the central nervous system, and is not immediately due to injury, but is possibly a delayed reaction to injury. Example conditions eligible for this study include chronic lower back pain, as well as phantom limb pain, complex regional pain syndrome, carpal tunnel syndrome, post-stroke limb pain, and repetitive strain injuries of the shoulder, arm or hand. In the pilot phase of the study, 30 subjects with chronic lower back pain and 30 subjects with chronic upper limb pain will receive 8 sessions of graded motor imagery virtual reality therapy. Contingent on the success of the pilot, defined as completion of 8 session with no adverse events, and trends indicating improvement of range of motion, pain, fear/avoidance, and depression symptoms, the randomized control trial phase of the research will proceed. In the randomized phase, subjects will be randomized into active or control conditions. Active condition subjects will receive 8 sessions of graded motor imagery in virtual reality, and control condition subjects will receive a non-embodied sham virtual reality experience. This study will investigate the safety and feasibility of this approach, as well as its effects on pain symptoms. This product is considered a non-significant risk device, as is explained in the accompanying letter from the sponsor, Karuna Labs Inc. A request for feedback from the presubmission program of the U.S. Food and Drug Administration has additionally been submitted.

Arms & Interventions

Arms

: Feasibility group

First phase group will involve piloting a novel virtual reality treatment for chronic pain to investigate feasibility and safety with a smaller number of patients

Interventions

Device: - Karuna Labs Virtual Reality Software

The subjects will engage in the three therapeutic modules: laterality, motor imagery, and 'mirroring.' The decision of which module to employ will be based on the subject's readiness and comfort on a case-by-case basis. A subject visit can be expected to last 40 minutes, with enough time to complete PHQ-9, and to accustom to the virtual reality setup by playing in a non-therapeutic virtual environment should they choose to do so. Time in the virtual reality is expected to last approximately 20 minutes per session.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Remedy Medical Group, San Francisco, California

Status

Address

Remedy Medical Group

San Francisco, California, 94102

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