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

Neuropathy;Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970006
• Other study ID #: 2016H0202
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: November 2019

Study information

• Verified date: August 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
United States	The Ohio Sate University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Swiss Federal Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Reduction Base on Patient Perception	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).	per minute in each virtual reality condition for 10 minutes in each reality condition.