Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial

Mount Sinai Health System

Status: Completed

Conditions: Spinal Cord Injuries; Chronic Pain; Neuralgia

Treatments: Device: Control IVR (cIVR); Device: Somatic IVR (sIVR); Device: Distractive IVR (dIVR)

Study type: Interventional

Funder types: Other

Identifiers

NCT04700033

GCO 18-0891

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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23 participants in 3 patient groups, including a placebo group

Somatic IVR

Experimental group

Description:

Participants with participate in Somatic IVR protocol three times per week for four weeks.

Treatment:

Device: Somatic IVR (sIVR)

Distractive IVR

Active Comparator group

Description:

Participants with participate in Distractive IVR protocol three times per week for four weeks.

Treatment:

Device: Distractive IVR (dIVR)

Control IVR

Placebo Comparator group

Description:

Participants with participate in Control IVR protocol three times per week for four weeks.

Treatment:

Device: Control IVR (cIVR)