Clinical trial NCT04060875: Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Official title: Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Karuna Labs Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Adverse events
timeFrame: 1-2 months
measure: Simulator Sickness Questionnaire
timeFrame: 1-2 months
measure: Visual Analogue Scale (VAS)
timeFrame: 1-2 months
Secondary outcomes:
measure: Fear and Avoidance Beliefs Questionnaire
timeFrame: 1-2 months
measure: OSWESTRY Disability Index Questionnaire
timeFrame: 1-2months
measure: Pain Catastrophizing Scale
timeFrame: 1-2 months
measure: Patient Health Questionnaire
timeFrame: 1-2 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Remedy Medical Group
state: California
Study officials:
affiliation: Vice President of Clinical Affairs
name: Michael Trujillo, PhD
role: PRINCIPAL_INVESTIGATOR
References: