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

NCT04060875 | Completed

• 1 other identifier: SAIRB-17-0063
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Low Back Pain; Fibromyalgia; Upper Extremity Dysfunction; Complex Regional Pain Syndromes; Phantom Limb Pain; Rheumatoid Arthritis; Carpal Tunnel Syndrome; Repetitive Strain Injury

Outcome Measures

Primary Outcomes (3)

• Adverse events

  Safety and feasibility

  1-2 months

• Simulator Sickness Questionnaire

  The questionnaire asks participants to score 16 symptoms on a four point scale (0-3). The scale measures susceptibility to nausea, general discomfort, stomach awareness, sweating, increased salivation, vertigo, burping, dizziness with eyes open, fullness of head, dizziness with eyes closed, difficulty focusing, headache, blurred vision, fatigue, and eye strain

  1-2 months

• Visual Analogue Scale (VAS)

  The pain Visual Analogue Scale is a unidimensional measure of pain intensity. Patients are asked to rate the intensity of their pain using a horizontal line 10 centimeters (100 mm) in length. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\])

  1-2 months

Secondary Outcomes (4)

• Fear and Avoidance Beliefs Questionnaire

  1-2 months

• OSWESTRY Disability Index Questionnaire

  1-2months

• Pain Catastrophizing Scale

  1-2 months

• Patient Health Questionnaire

  1-2 months

Study Arms (1)

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

Device: Karuna Labs Virtual Reality Software

Interventions

Karuna Labs Virtual Reality Software DEVICE

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.

Feasibility group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People diagnosed with chronic pain disorders of the lower back or upper limbs with a continual duration of at least 6 months

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karuna Labs Inc.: lead

Study Sites (1)

Remedy Medical Group

San Francisco, California, 94102, United States

Location

Related Publications (1)

• Saby A, Alvarez A, Smolins D, Petros J, Nguyen L, Trujillo M, Aygun O. Effects of Embodiment in Virtual Reality for Treatment of Chronic Pain: Pilot Open-Label Study. JMIR Form Res. 2024 Feb 16;8:e34162. doi: 10.2196/34162.

  PMID: 38363591 DERIVED

MeSH Terms

Conditions

Chronic Pain; Low Back Pain; Fibromyalgia; Complex Regional Pain Syndromes; Phantom Limb; Arthritis, Rheumatoid; Carpal Tunnel Syndrome; Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Peripheral Nervous System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Arthritis; Joint Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Sprains and Strains; Wounds and Injuries

Study Officials

• Michael Trujillo, PhD

  Vice President of Clinical Affairs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 19, 2019
• Study Start: September 21, 2017
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Locations

US (1)