Trials / Completed
CompletedNCT02970006
Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Ohio State University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | neurovisual stimulation | a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation) |
Timeline
- Start date
- 2016-10-01
- Primary completion
- 2018-10-01
- Completion
- 2019-11-01
- First posted
- 2016-11-21
- Last updated
- 2021-09-20
- Results posted
- 2021-09-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02970006. Inclusion in this directory is not an endorsement.