Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Keywords
Abstract
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.
Dates
Last Verified: | 07/31/2019 |
First Submitted: | 07/28/2019 |
Estimated Enrollment Submitted: | 08/14/2019 |
First Posted: | 08/18/2019 |
Last Update Submitted: | 08/14/2019 |
Last Update Posted: | 08/18/2019 |
Actual Study Start Date: | 09/20/2017 |
Estimated Primary Completion Date: | 08/19/2019 |
Estimated Study Completion Date: | 09/19/2019 |
Condition or disease
Intervention/treatment
Device: Feasibility group
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
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: Feasibility group 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. |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Sampling method | Non-Probability Sample |
Accepts Healthy Volunteers | Yes |
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 |
Outcome
Primary Outcome Measures
1. Adverse events [1-2 months]
2. Simulator Sickness Questionnaire [1-2 months]
3. Visual Analogue Scale (VAS) [1-2 months]
Secondary Outcome Measures
1. Fear and Avoidance Beliefs Questionnaire [1-2 months]
2. OSWESTRY Disability Index Questionnaire [1-2months]
3. Pain Catastrophizing Scale [1-2 months]
4. Patient Health Questionnaire [1-2 months]