Clinical trial NCT03592394: Virtual Reality for Chronic Neuropathic Pain
Official title: Immersive Virtual Reality for Chronic Neuropathic Pain After Spinal Cord Injury: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Spinal Cord Injuries
Neuropathic Pain
Lead sponsor: Burke Medical Research Institute
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Neuropathic Pain Scale
timeFrame: Baseline compared with immediately after intervention, and 1 month follow up
Secondary outcomes:
measure: Upper Extremity Motor Score (UEMS)
timeFrame: Baseline, immediately after intervention, and 1 month follow up
measure: Modified Ashworth Scale
timeFrame: Baseline, immediately after intervention, and 1 month follow up
measure: Spinal Cord Independence Measure (SCIM III)
timeFrame: Baseline, immediately after intervention, and 1 month follow up
measure: Beck Depression Inventory
timeFrame: Baseline, immediately after intervention, and 1 month follow up
measure: Immersive Tendencies Questionnaire (ITQ)
timeFrame: Baseline, immediately after intervention, and 1 month follow up
measure: The Presence Questionnaire
timeFrame: Baseline, post-intervention, and 1 month follow up
measure: Patient's Global Impression of Change
timeFrame: Baseline, immediately after intervention, and 1 month follow up
measure: Transcranial Magnetic Stimulation
timeFrame: Baseline, immediately after intervention, and 1 month follow up
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Medical Research Institute
state: New York
Study officials:
affiliation: Burke Medical Research Institute
name: Kathleen Friel, PhD
role: STUDY_DIRECTOR
References: