Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
CompletedNCT04060875
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain
- 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
- Interventions
- Device: Karuna Labs Virtual Reality Software
- Sponsor
- Karuna Labs Inc.
- Start date
- 2017-09-21
- Primary completion
- 2021-06-01
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04060875