Trial Outcomes & Findings for Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion (NCT NCT02970006)
NCT ID: NCT02970006
Last Updated: 2021-09-20
Results Overview
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.
COMPLETED
NA
15 participants
At each hour from 1-5 hours post intervention
2021-09-20
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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15
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Neurovisual Stimulation
n=15 Participants
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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Age, Continuous
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47.7 years
STANDARD_DEVIATION 9.56 • n=15 Participants
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Sex: Female, Male
Female
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5 Participants
n=15 Participants
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Sex: Female, Male
Male
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10 Participants
n=15 Participants
|
|
Region of Enrollment
United States
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15 Participants
n=15 Participants
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PRIMARY outcome
Timeframe: At each hour from 1-5 hours post intervention10 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.
Outcome measures
| Measure |
Neurovisual Stimulation
n=14 Participants
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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Average Pain Reduction Post Intervention
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2.72 score on a scale
Standard Error 0.6
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SECONDARY outcome
Timeframe: per minute in each virtual reality condition for 10 minutes in each reality condition.Population: 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.
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).
Outcome measures
| Measure |
Neurovisual Stimulation
n=15 Participants
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)
|
|---|---|
|
Pain Reduction Base on Patient Perception
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0.7 average score on scale of pain reduction
Standard Error 0.25
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Adverse Events
Neurovisual Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vibhor Krishna, MD
The Ohio State University- Neurological Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place