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

NCT04700033 | Completed

• 1 other identifier: GCO 18-0891
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuralgia; Spinal Cord Injuries; Chronic Pain

Keywords

Virtual Reality; Neuronal Plasticity; Neurological Rehabilitation; Immersive Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Neuropathic Pain Symptom Inventory (NPSI)

  Neuropathic Pain Symptom Inventory (NPSI): This scale was developed to assess both the quantitative and qualitative qualities of neuropathic pain (NP). It includes 12 items, assessing spontaneous pain, brief attacks of pain, provoked pain and abnormal sensations in the painful area. This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention. Total score range for NPSI is 0-100, higher scores indicate more severity.

  Up to 10 Weeks

Secondary Outcomes (8)

• User Experience Score (UES)

  14 Days

• Spinal Cord Independence Measure (SCIM III)

  Up to 10 Weeks

• Numerical Pain Rating Scale (NPRS)

  16 Days

• Beck Depression Inventory (BDI)

  Up to 10 Weeks

• Patient's Global Impression of Change (PGIC)

  Up to 10 Weeks

Study Arms (3)

Somatic IVR

EXPERIMENTAL

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

Device: Somatic IVR (sIVR)

Distractive IVR

ACTIVE COMPARATOR

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

Device: Distractive IVR (dIVR)

Control IVR

PLACEBO COMPARATOR

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

Device: Control IVR (cIVR)

Interventions

Somatic IVR (sIVR) 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.

Somatic IVR

Distractive IVR (dIVR) 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.

Distractive IVR

Control IVR (cIVR) 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.

Control IVR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David Putrino, PT, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, PI and Outcome Assessor remain blinded for the entirety of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Rehabilitation Innovation

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: July 17, 2019
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)