Virtual Reality for Chronic Neuropathic Pain

Last updated: July 8, 2019
Sponsor: Kathleen Friel
Overall Status: Active - Not Recruiting

Phase

3

Condition

Spinal Cord Injuries

Chronic Pain

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT03592394
BRC527
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presence of chronic neuropathic pain at or below SCI level for at least 6 monthsfollowing trauma or disease of the spinal cord;

  • A pain intensity of at least 4 out of 10 in the numerical rating scale (NRS) in theNeuropathic Pain Scale (NPS) test at both screening (baseline) and randomization (pre-evaluation);

  • Stable pharmacological treatment for at least 2 weeks prior to the study andthroughout 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 averagestrength of the muscles below the level of the lesion <3, D= sensorimotor incompletewith average muscle strength >3);

  • Cervical level of lesion (C2 to T1) with presence of pain in the upper extremities

Exclusion

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 inthe skull, and metal inside the skull;

  • Medically unstable

Study Design

Total Participants: 40
Study Start date:
July 01, 2016
Estimated Completion Date:
December 31, 2019

Study 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.

Connect with a study center

  • Burke Medical Research Institute

    White Plains, New York 10605
    United States

    Site Not Available

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