Virtual Reality for Chronic Neuropathic Pain

NCT03592394 | Unknown Phase 3

• 1 other identifier: BRC527
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that SCI patients using immersive IVR training will show improved reduction of neuropathic pain that will outlast the training sessions and transfers into daily life.

Conditions

Spinal Cord Injuries; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Neuropathic Pain Scale

  It includes 11 items, assessing global pain intensity, unpleasantness, and one item which allows the patient to describe the temporal aspects of their pain and its qualities in their own words. The remaining 8 items assess specific NP qualities: "Sharp," "Hot," "Dull," "Cold," "Sensitive," "Itchy," "Deep," and "Surface." This is a sensitive tool for measuring changes in neuropathic pain after a therapeutic intervention.

  Baseline compared with immediately after intervention, and 1 month follow up

Secondary Outcomes (8)

• Upper Extremity Motor Score (UEMS)

  Baseline, immediately after intervention, and 1 month follow up

• Modified Ashworth Scale

  Baseline, immediately after intervention, and 1 month follow up

• Spinal Cord Independence Measure (SCIM III)

  Baseline, immediately after intervention, and 1 month follow up

• Beck Depression Inventory

  Baseline, immediately after intervention, and 1 month follow up

• Immersive Tendencies Questionnaire (ITQ)

  Baseline, immediately after intervention, and 1 month follow up

Study Arms (2)

Somatic IVR (s-IVR)

ACTIVE COMPARATOR

This group will use an Immersive Virtual Reality (Gear VR) device to focus on encouraging 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.

Device: Immersive Virtual Reality (Gear VR)

Distractive IVR (d-IVR)

ACTIVE COMPARATOR

This group will use an Immersive Virtual Reality (Gear VR) device to focus 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.

Device: Immersive Virtual Reality (Gear VR)

Interventions

Immersive Virtual Reality (Gear VR) DEVICE

Immersing the user in a total visual environment.

Distractive IVR (d-IVR); Somatic IVR (s-IVR)

Eligibility Criteria

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

You may qualify if:

• Presence of chronic 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 4 out of 10 in the numerical rating scale (NRS) in the Neuropathic Pain Scale (NPS) test at both screening (baseline) and randomization (pre-evaluation);
• Stable pharmacological treatment for at least 2 weeks prior to the study and throughout the trial;
• Incomplete lesion (American Spinal Injury Association Impairment Scale, AIS B, C or D; B= motor complete, sensory incomplete; C= sensorimotor incomplete with an average strength of the muscles below the level of the lesion \<3, D= sensorimotor incomplete with average muscle strength \>3);
• Cervical level of lesion (C2 to T1) with presence of pain in the upper extremities

You may not qualify if:

• Presence of severe pain of other origin, such as musculoskeletal pain
• Psychiatric or other neurological disorders
• Head injuries causing cognitive or visual impairment
• Severe vertigo
• Presence of potential risk factors for brain stimulation (TMS): history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull;
• Medically unstable

Sponsors & Collaborators

• Kathleen Friel: lead

Study Sites (1)

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Kathleen Friel, PhD

  Burke Medical Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lab Director, Clinical Laboratory for Early Brain Injury Recovery

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: July 19, 2018
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)