P-105 - Efficacy of a Novel Audio-Visual Neuromodulation device for Neuropathic Pain: A Randomized Controlled Trial

Abstract Title: Efficacy of a Novel Audio-Visual Neuromodulation device for Neuropathic Pain: A Randomized Controlled Trial

Background: Neuropathic Pain (NP) affects 10% of the general population decreasing the quality of life for millions of Americans while contributing to higher physical and mental health care costs, estimated to be up to $30,000 in direct and indirect costs annually [1-6]. Currently, treatments for NP include a variety of medications such as tricyclic antidepressants, anticonvulsants, and serotonin-norepinephrine reuptake inhibitors which show limitations in efficacy as well as burdensome side effects and drug resistance [7,8]. Opiate medications are also commonly used by those with NP, which is effective for reducing pain, however come with stigma, dependency, and side effects [9]. There is a strong need for new innovative treatments that can augment or replace current frontline to improve outcomes for patients with NP.

The present study investigated the Sana Device, a neuromodulatory Audio-Visual Stimulation (AVS) device designed to remediate the symptoms of NP. The AVS program immediately encourages beneficial mental states and broadly promotes a more balanced cross-hemispheric signal through neural entrainment. The benefits apply broadly across psychological conditions that can benefit from reductions in anxiety, poor sleep quality, depression as well as the symptoms of neuropathological disorders such as NP.

Purpose/Objectives: The pre-specified primary objective was to evaluate the efficacy of a novel Audio Visual Stimulation (AVS) device, the Sana Device, compared to sham device after 8 weeks of treatment and 4 weeks of non-use. The 4 week non-use period was a critical aspect in this study design that served to washout any temporary efficacy signals produced by the Sana Device or Sham enabling any durable reduction in NP severity to be detected after 4-weeks of non-use. Secondary objectives examining changes in anxiety, depression, and quality of life were also examined after 8 weeks of use and 4 weeks of non-use.

Methods: The Mt. Sinai Neuropathic pain trial was a parallel-arm, randomized, double-blinded, and sham controlled study that evaluated the effectiveness of a novel AVS device (Sana) for reducing the severity of neuropathic pain in 64 participants. Outcomes were assessed at baseline, after 8-weeks of once daily use of their assigned Sana or Sham device, and after an additional 4 weeks of discontinued use. The 4-week non-use period was included in the study design in order to allow temporary relaxation effects produced by the partially active sham device to dissipate. The primary outcome was the Neuropathic Pain Symptom Inventory (NPSI). The 5 subscales of the NPSI were analyzed to examine changes in burning pain, pressing pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia. Other outcomes examined changes in depression (PHQ-9), anxiety (GAD-7), sleep quality (PSQI), and quality of life (PGIC-QOL). Finally, an analysis of daily medication usage logs was conducted to examine differential changes in usage between groups over the study period.

Results: For the NPSI Total there were statistically significant improvements in the Active arm that were greater than those in the Sham Arm at Week-14 (Mean Difference = 10.04, p = 0.01). The effect size for improvement of the Active group over Sham (Cohen’s D for Between Subjects) was calculated to be 0.7, which can be considered a strong effect size.

Within the NPSI subscales examined, there were statistically significant improvements in the Active arm over sham for the Burning Pain (Mean Difference = 21.31, p = 0.004) and Pressing Pain Subscales (ITT: Mean Difference = 13, p = 0.03).

There were no significant differences for the outcomes measuring depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), or quality of life (PGIC-QOL) at 14 weeks. This may be due to a potentially partially beneficial sham device. It is possible that that any habit that encourages a patient with chronic pain to rest completely for 15-20 minutes multiple times a day, as prescribed by both the active and sham devices, may generate positive clinical results and benefits.

The results of the medication log analysis for the study duration indicate significant differences in change of medication usage for the active compared to sham for Anxiolytic and Sedatives (active change = -83%, sham change = +30%, p = 0.009), Muscle Relaxants (active change = -91%, sham change = -12%, p = 0.02) Opiate Analgesics (active change -15%, sham change = +45%, p = 0.03), Antidepressants (active change = -67%, sham change = -3%, p < = 0.001), and Anticonvulsants (active change = -78%, sham change = -8%, p < = 0.001).

Conclusions/Implications for future research and/or clinical care: The Sana device demonstrated efficacy in reducing neuropathic pain that was shown to be durable after 4 weeks of discontinued use. Analyses of the NPSI subscales suggested that the Sana device was most effective at relieving burning and pressing NP. Analysis of medication usage eliminates the concern that differential changes between groups explain the primary results. In addition, these results suggest that the Sana device may reduce the reliance on opiate and anticonvulsant medications. This study provides solid evidence of benefit in the form of significant symptom intensity reductions for patients with NP who have used the Sana device and supports the potential role of the Sana device as a novel treatment modality for neuropathic pain.

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