Virtual Reality for Chronic Neuropathic Pain

NCT ID: NCT03592394

Last Updated: 2019-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-12-31

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.

Detailed Description

Neuropathic pain (NP) affects 40 to 70% of people with SCI and is a very disabling clinical condition. The definitions of NP as well as its neurophysiology are widely discussed in the literature. Many treatment options have been offered, but provide limited effects, leaving people with SCI with a reduced quality of life.

Pain is a very complex experience that depends strongly on cognitive, emotional, and educational influences. Despite intensive investigations, the cause of neuropathic pain often remains unknown. A careful assessment of the pain including the use of tools to objectively measure pain will help with the diagnosis and the quantification of the damage. These tools include: 1) Laboratory testing that uses quantitative tests and measures objective responses in neurophysiology, sensory evoked potentials...etc.; 2) Quantitative sensory testing, that tests the perception of pain in response to external stimuli; 3) Bedside examination: physicians assessment on location, quality and intensity of pain; 4) Pain questionnaires, depending entirely on the subject's self-reported experience.

When spinal cord injury occurs, the spinal somatosensory circuit is thought to generate aberrant nociceptive impulses that the brain interprets as pain. Thalamic circuits may also serve as amplifiers of nociceptive signals. Sensory deafferentation after injury to the spinal cord produces extensive and long-lasting reorganization of the cortical and subcortical sensory maps. It has been suggested that pain and phantom limb sensations are the consequence of those cortical plasticity change. Therefore, strategies aimed at reversing or modulating the somatosensory neural reorganization may be valuable alternative approaches to neuropathic pain. Immersive virtual reality (IVR) is an emerging approach to the treatment of neuropathic pain conditions in SCI. Despite promising initial studies, IVR therapy has not yet been made widely available to individuals with SCI, because equipment is expensive and can be difficult for clinicians to use, especially those with limited experience with technology. However, with the development of 'plug and play', low-cost IVR devices such as the Oculus Rift, Gear VR and Google Cardboard, IVR no longer requires such specific technical knowledge. As a result, IVR is now a feasible and affordable treatment option for neuropathic pain.

The investigators believe that IVR neurorehabilitation exploits the idea of inducing activation in action observation, motor imagery, and processing systems, which in turn, should activate downstream cortical areas involved in movement and motor imagery. Also, perturbations of the somatosensory system associated with central pain can be reversed or modulated by employing motor imagery and related task execution combined with visual illusions. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Somatic IVR (s-IVR)

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.

Group Type: ACTIVE_COMPARATOR

Immersive Virtual Reality (Gear VR)

Intervention Type: DEVICE

Immersing the user in a total visual environment.

Distractive IVR (d-IVR)

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.

Group Type: ACTIVE_COMPARATOR

Immersive Virtual Reality (Gear VR)

Intervention Type: DEVICE

Immersing the user in a total visual environment.

Interventions

Immersive Virtual Reality (Gear VR)

Immersing the user in a total visual environment.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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

Sponsors

Kathleen Friel

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Friel

Lab Director, Clinical Laboratory for Early Brain Injury Recovery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kathleen Friel, PhD

Role: STUDY_DIRECTOR

Burke Medical Research Institute

Locations

Burke Medical Research Institute

White Plains, New York, United States

Countries

United States

Other Identifiers

BRC527

Identifier Type: -

Identifier Source: org_study_id