Clinical trial NCT04700033: Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
Official title: Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuralgia
Spinal Cord Injuries
Chronic Pain
Keywords: Virtual Reality
Neuronal Plasticity
Neurological Rehabilitation
Immersive Virtual Reality
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a single center, prospective randomized controlled clinical trial. The purpose of the study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to provide critical information about the efficacy of Immersive Virtual Reality (IVR) to decrease the experience of neuropathic pain in the upper and lower extremities of people with a spinal cord injury.

Detailed description: When a spinal cord injury occurs, the spinal somatosensory circuit is thought to generate aberrant nociceptive impulses that the brain interprets as pain. Neuropathic pain (NP) affects 40 to 70% of people with SCI and is a very disabling clinical condition. Many treatment options have been offered, but provide limited effects, leaving people with SCI with a reduced quality of life. The study team believes that Immersive Virtual Reality (IVR) neurorehabilitation has the potential to be an effective treatment for chronic neuropathic pain. For this reason, the objective of this study is to evaluate the feasibility of using a virtual reality device to decrease chronic neuropathic pain in individuals with spinal cord injury.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury survivors (chronic only)
* Presence of neuropathic pain at or below SCI level for at least 6 months following trauma or disease of the spinal cord
* A pain intensity of at least 2 out of 10 in the numerical pain rating scale (NPRS) test at baseline
* Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial

Exclusion Criteria:

* Psychiatric or other neurological disorders (Participants will not be excluded for having a SCI, if they score 0-30 points on the BDI, or if they report having anxiety)
* Head injuries causing cognitive or visual impairment
* Severe vertigo

Primary outcomes:
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Up to 10 Weeks
Secondary outcomes:
measure: User Experience Score (UES)
timeFrame: 14 Days
measure: Spinal Cord Independence Measure (SCIM III)
timeFrame: Up to 10 Weeks
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 16 Days
measure: Beck Depression Inventory (BDI)
timeFrame: Up to 10 Weeks
measure: Patient's Global Impression of Change (PGIC)
timeFrame: Up to 10 Weeks
measure: Immersive Tendencies Questionnaire (ITQ)
timeFrame: Up to 10 Weeks
measure: UQO- Presence Questionnaire (UPO-PQ)
timeFrame: 16 Days
measure: Neuropathic Pain Scale (NPS)
timeFrame: Up to 10 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: David Putrino, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: