Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04060875 |
Other study ID # |
SAIRB-17-0063 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 21, 2017 |
Est. completion date |
June 1, 2021 |
Study information
Verified date |
June 2021 |
Source |
Karuna Labs Inc. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.