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

NCT ID: NCT04700033

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-17
• Study Completion Date: 2022-05-05

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.

Conditions

Neuralgia; Spinal Cord Injuries; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Somatic IVR

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

Group Type: EXPERIMENTAL

Somatic IVR (sIVR)

Intervention Type: DEVICE

This intervention will consist of an IVR protocol that is focused on somatic interaction that encourages disassociation between pain and visualization and movement of the affected limbs. Subjects in this group will be exposed to an IVR environment that cycles them through a series of stretching and mobility exercises for the affected limbs bilaterally.

Distractive IVR

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

Group Type: ACTIVE_COMPARATOR

Distractive IVR (dIVR)

Intervention Type: DEVICE

This intervention will consist of an IVR that is focused on distracting the subject from the pain. Subjects in this group will be exposed to a variety of engaging landscape IVR environments, without the ability to visualize their own body.

Control IVR

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

Group Type: PLACEBO_COMPARATOR

Control IVR (cIVR)

Intervention Type: DEVICE

This intervention will consist of an IVR exposure to a black screen for 20 minutes. No light, images or scenery will be present in the IVR and it will serve as a control condition for the trial.

Interventions

Somatic IVR (sIVR)

This intervention will consist of an IVR protocol that is focused on somatic interaction that encourages disassociation between pain and visualization and movement of the affected limbs. Subjects in this group will be exposed to an IVR environment that cycles them through a series of stretching and mobility exercises for the affected limbs bilaterally.

Intervention Type: DEVICE

Distractive IVR (dIVR)

This intervention will consist of an IVR that is focused on distracting the subject from the pain. Subjects in this group will be exposed to a variety of engaging landscape IVR environments, without the ability to visualize their own body.

Intervention Type: DEVICE

Control IVR (cIVR)

This intervention will consist of an IVR exposure to a black screen for 20 minutes. No light, images or scenery will be present in the IVR and it will serve as a control condition for the trial.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

David Putrino

Director of Rehabilitation Innovation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Putrino, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 18-0891

Identifier Type: -

Identifier Source: org_study_id