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| Name | Class |
|---|---|
| Swiss Federal Institute of Technology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neurovisual stimulation | Device | a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vibhor R Krishna, MBBS | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio Sate University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33259460 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neurovisual Stimulation | 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. neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Neurovisual Stimulation | 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. neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | score on a scale | At each hour from 1-5 hours post intervention |
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The experiment included 2 sessions occurring at 24 hours interval, the first session was used for clinical assessment and the personalization of the visual illumination administered in the virtual environment, while the experimental protocol was performed the second day. The duration of each session was between 90-120 minutes. Adverse events were monitored over that time.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neurovisual Stimulation | 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. neurovisual stimulation: a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vibhor Krishna, MD | The Ohio State University- Neurological Institute | 6142939274 | Vibhor.Krishna@osumc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2017 | Jul 16, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009443 | Neuritis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| per minute in each virtual reality condition for 10 minutes in each reality condition. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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). | Patients will rate their pain reduction on a scale of 0-6, each minute in each of the three virtual reality conditions. The pain score change reported is an average of all time points in all virtual reality settings. A change in pain rating was calculated between different SCS and VR conditions. Percentage pain reduction was then calculated to test whether SCS combined with VR reduced pain more significantly than VR alone. The calculation done was a mean score of all pain ratings at all points. | Posted | Mean | Standard Error | average score on scale of pain reduction | per minute in each virtual reality condition for 10 minutes in each reality condition. |
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| 15 |
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