Treatment of Central Neuropathic Pain caused by Neuromyelitis Optica Spectrum Disorder
Embargo until
2020-05-01
Date
2019-04-12
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Publisher
Johns Hopkins University
Abstract
Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing autoimmune disease of the central nervous system that preferentially targets the optic nerves and spinal cord, leading to paralysis, blindness and death. Severe pain is a disabling component of the disease with up to 91% of patients reporting pain that is classified as central neuropathic pain (CNP), which is often refractory to treatment commonly used for peripheral neuropathy. This dissertation is comprised of two parallel studies both meant to inform a large Phase III study.
The first part involves a Phase II randomized single blinded, sham-controlled study proposes to evaluate the acceptability, feasibility, safety and efficacy of a novel technique called Scrambler Therapy for CNP treatment in patients with NMOSD. Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways. It has been examined for treatment of peripheral neuropathy with favorable outcomes, but there exists little data for use in CNP. Twenty-two participants were recruited from the Johns Hopkins NMO Clinic and were eligible for inclusion if they had CNP rated at 4 or higher on an 11-point numeric rating scale (0-10). Participants were randomized 1:1 and blinded to undergo either Scrambler Therapy or sham daily for 10 days. The primary outcome was a significant reduction in pain following 10-day treatment in the Scrambler intervention versus sham arm. The secondary outcome was safety, acceptability and feasibility. Sustainability of effect was also be evaluated. As the first-ever interventional pain study in NMOSD, it sets the foundation for future work that focuses on alleviating the physical and emotional suffering of patients who have neuropathic pain. As the first known study to investigate use of Scrambler for central neuropathic pain treatment, it further acts as a model for other diseases, including multiple sclerosis, spinal cord injury and stroke.
The second study involves a cross-sectional assessment of pain on co-occurring symptoms in patients with NMOSD, which include anxiety, depression and sleep disturbance, and the impact of pain on quality of life (QoL). This involves a convenience sampling of 72 patients diagnosed with NMOSD who completed each of the following surveys to determine pain, health-related QoL, anxiety, depression and sleep disturbance, respectively: Brief Pain Inventory (BPI), Short Form-36 Health Inventory (SF-36), Neuro-QoL [Quality of Life in Neurological Disorders] Short Form v1.0 – Anxiety, Neuro-QoL Short Form v1.0 – Depression, and Neuro-QoL Short Form v1.0 - Sleep Disturbance. This study broadens the understanding of how intervening on pain can enhance QoL.
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Keywords
neuromyelitis optica, neuropathic pain, quality of life