Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
Completed
Conditions 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
In brief
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.
Key facts
- Study ID
- NCT04060875
- Run by
- Karuna Labs Inc.
- People needed
- 24
- Starts
- 2017-09-21
- Expected to finish
- 2021-06-01
- Last updated by the study team
- 2021-06-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- Remedy Medical Group — San Francisco, California, United States
Full record on ClinicalTrials.gov
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