N/A
N=15
Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion
Neuropathy;Peripheral
Bottom Line
View on ClinicalTrials.gov: NCT02970006 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Average Pain Reduction Post Intervention — 2.72 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- neurovisual stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain Reduction Post Intervention |
2.72 | — |
| SECONDARY Pain Reduction Base on Patient Perception |
0.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02970006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.