Clinical Trial: Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion

Brief Summary: The study hypothesis is that spinal cord stimulation (SCS) combined with virtual leg illumination (provided through a wearable headset (OculusRift, OculusVR, Irvine, CA) and a custom-designed virtual reality leg scenario) will lead to controlled analgesia induction, boosting analgesic effects obtained with standard SCS treatments and will further be associated with changes in the perception of the affected body part.

Detailed Summary: Epidural spinal cord stimulation (SCS) is an approved treatment for truncal and extremity neuropathic pain. The mechanisms underlying the efficacy of SCS are unknown. Recent advances in cognitive neuroprosthetics using virtual reality allow for modulation of body perception and bodily experience, which has also been shown to modulate pain perception. The present research proposal plans to merge expertise in cognitive neuroprosthetics with neuromodulation techniques in order to test the analgesic properties of the combination of epidural spinal cord stimulation with a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation). The investigators propose to study this hypothesis prospectively in 25 patients with implanted SCS systems for the treatment of chronic neuropathic pain. Primary outcomes will be pain reduction (based on subjective, functional and physiological measures) and changes in body perception (based on subjective and objective measures). The present study will generate a proof-of-concept for the application of neuro-visual stimulation for the treatment of chronic pain and will form the basis for future NIH funding application.
Sponsor: Ohio State University

Current Primary Outcome: Pain reduction [ Time Frame: 1-5 hours ]

Subjective pain perception will be measured by pain ratings on a 10cm visual continuous analog scale (VAS). Patients will be ask to rate their pain, ranging from "no pain" (bottom part of the scale) to "the worst imaginable pain" (upper part of the scale) (Huskisson 1974).


Original Primary Outcome: Same as current

Current Secondary Outcome: Body perception [ Time Frame: 1-5 hours ]

Validated questionnaires developed by the collaborators (Swiss Federal Institute of Technology) will be used in order to investigate induced changes in leg perception and ownership. In particular, we will assess: 1) feeling of ownership towards the leg shown in the virtual reality set-up (leg ownership); 2) tactile sensations felt on the virtual legs, depending on the different conditions of SCS and visual stimulation. Patients will be asked to indicate how much they agreed with each item using a 7-point colored vertical Likert scale ranging from 0 (complete disagreement, the bottom extreme, red point) to +6 (complete agreement, the top extreme, green point).


Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: November 16, 2016
Date Started: October 2016
Date Completion: November 2019
Last Updated: November 17, 2016
Last Verified: November 2016