Abstract Details

Title Phase II Randomized Controlled Trial Evaluating Scrambler Therapy for Central Neuropathic Pain Treatment in Patients with Neuromyelitis Optica Spectrum Disorder

Topic Autoimmune Neurology

Presentation(s) S43 - Immunotherapies and Drug Trials in Autoimmune Neurological Disorders (4:36 PM-4:47 PM)

Poster/Presentation
Number 007

Background

Neuromyelitis optica spectrum disorder (NMOSD) is a recurrent autoimmune disease of the central nervous system that preferentially targets the optic nerves and spinal cord. Neuropathic pain is a severely disabling component of the disease impacting mood, mobility and quality of life. There is no standard of care for central neuropathic pain treatment, and peripheral neuropathy medication use is often insufficient. Scrambler therapy is a non-invasive pain modifying intervention that utilizes peripheral nerve stimulation of ascending C-fibers with the intent of re-organizing maladaptive signaling pathways.

Objective

To assess the acceptability, feasibility and effectiveness of Scrambler therapy versus sham in a trial of 22 NMOSD patients with central neuropathic pain.

Design/Methods We conducted a sham-controlled trial in 22 patients with NMOSD who have neuropathic pain attributable to a spinal cord lesion rated at a level of 4 or higher on an 11-point numeric rating scale (NRS). Participants were randomly assigned to receive Scrambler treatment versus sham at a 1:1 ratio. Effectiveness is based on degree of improvement in pain and compares NRS scores in the treatment versus sham groups at end of treatment, and at 4 and 8-week follow-up. Acceptability and feasibility are assessed via patient report of perceived benefit, adherence to visit schedule and safety.

Results Twenty women and two men were recruited and treated, 11 per arm. Preliminary analyses found that those receiving treatment significantly improved over the course of treatment from an average pain score of 5.6 to 1.5 (p=0.0004). In the sham arm, the average pain score improved modestly from 5.6 to 4.3, but this was not significant (p=0.09). No safety concerns have emerged in the treatment group.

Conclusions Scrambler therapy is an effective and feasible intervention that significantly reduces pain. This is the first-ever interventional pain study for patients with NMOSD in the United States.

Authors/Disclosures
Maureen A. Mealy, PhD, RN PRESENTER	No disclosure on file
	No disclosure on file
Ruth Andrea Salazar Camelo, MD (Johns Hopkins School of Medicine)	Dr. Salazar Camelo has nothing to disclose.
	No disclosure on file
Lawrence Cook, PhD (University of Utah Data Coordinating Center)	The institution of Dr. Cook has received research support from CDC. The institution of Dr. Cook has received research support from The Guthy-Jackson Charitable Foundation. The institution of Dr. Cook has received research support from Utah Highway Safety Office. The institution of Dr. Cook has received research support from NIH.
	No disclosure on file
Michael Levy, MD, PhD, FAAN (Massachusetts General Hospital/Harvard Medical School)	Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Pharma. Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB Pharma. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Levy has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Various law firms. The institution of Dr. Levy has received research support from National Institutes Health.

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