Clinical trial NCT02970006: Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion
Official title: Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathy;Peripheral
Keywords: spinal cord stimulation
virtual reality
full body illusion
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2016-11-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-and older at the time of enrollment
2. Patients carrying a diagnosis of CPRS type 125 or chronic refractory neuropathic leg pain following FBS4
3. Patients who have implanted epidural SCS
4. The SCS implantation for at least three months prior to enrollment
5. Patients with efficacious SCS as defined by ≥ 50% pain improvement after switching SCS from an OFF state to an ON state ('optimal' stimulation efficacy)
6. Patients willing and able to provide informed consent

Exclusion Criteria:

1. Patients who are unable to effectively or efficiently communicate for example patients suffering from speech deficits (dysarthria, aphasia) or are non-English speaking.
2. Patients with history of prior cranial surgery, significant brain lesions for example intracranial tumors, strokes etc.
3. Non efficacious response to SCS \<50% pain improvement with optimal stimulation parameters
4. Evidence of untreated psychiatric disorders or drugs/alcohol abuse.
5. History of seizures

Primary outcomes:
measure: Average Pain Reduction Post Intervention
timeFrame: At each hour from 1-5 hours post intervention
Secondary outcomes:
measure: Pain Reduction Base on Patient Perception
timeFrame: per minute in each virtual reality condition for 10 minutes in each reality condition.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio Sate University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Vibhor R Krishna, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Solca M, Krishna V, Young N, Deogaonkar M, Herbelin B, Orepic P, Mange R, Rognini G, Serino A, Rezai A, Blanke O. Enhancing analgesic spinal cord stimulation for chronic pain with personalized immersive virtual reality. Pain. 2021 Jun 1;162(6):1641-1649. doi: 10.1097/j.pain.0000000000002160.