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

NCT02970006 | Completed Results

• 1 other identifier: 2016H0202
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathy;Peripheral

Keywords

spinal cord stimulation; virtual reality; full body illusion

Outcome Measures

Primary Outcomes (1)

• Average Pain Reduction Post Intervention

  10 point Visual Analog pain rating Scale. Subjective pain perception will be measured by pain ratings on a 10cm visual continuous analog scale (VAS). Patients rate their pain, ranging from "no pain" (bottom part of the scale) to "the worst imaginable pain" (upper part of the scale) (Huskisson 1974). The pain reduction will be an average total of the pain scores taken at hours 1, 2, 3, 4, and 5.

  At each hour from 1-5 hours post intervention

Secondary Outcomes (1)

• Pain Reduction Base on Patient Perception

  per minute in each virtual reality condition for 10 minutes in each reality condition.

Study Arms (1)

neurovisual stimulation

EXPERIMENTAL

Participants in this study will be adults who have already undergone implantation of SCS for the treatment of their pain conditions. The study involves no further treatment or intervention. Subjects will be approached for participation in this study during their routine postoperative clinical visit to the Center for Neuromodulation at the Ohio State University (OSU).All eligible patients will undergo a one-day visit for the virtual reality and full body illusion intervention. This research will also investigate leg embodiment and leg analgesic effects during SCS integrated with different patterns of virtual leg illumination.

Device: neurovisual stimulation

Interventions

neurovisual stimulation DEVICE

a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)

neurovisual stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead
• Swiss Federal Institute of Technology: collaborator

Study Sites (1)

The Ohio Sate University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 33259460 DERIVED

MeSH Terms

Conditions

Neuritis

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Vibhor Krishna, MD
• Organization: The Ohio State University- Neurological Institute

Vibhor.Krishna@osumc.edu

6142939274

Study Officials

• Vibhor R Krishna, MBBS

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 21, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2019
• Last Updated: September 20, 2021
• Results First Posted: September 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)