Empower Neuromodulation System, a home-use device for the treatment of anxiety disorders

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Abstract Generalized anxiety disorder (GAD) is a chronic, recurring condition that affects approximately 6.4 million American adults each year. GAD is one of the most common anxiety disorders and is costly to treat, with medical costs that are 33% higher than other anxiety disorders. Recent weekly GAD-2 surveys by the U.S. Census Bureau have indicated that the prevalence of GAD may be sharply increasing as a result of the COVID-19 pandemic. As of July 2020, 36% of American adults have symptoms of GAD vs. 8% before the pandemic. Taken together, there is a need for a comprehensive therapy to effectively treat GAD. First-line treatments for GAD include medication (e.g. SSRIs, SNRIs), cognitive behavioral therapy, or both in combination. Unfortunately, these all have shown modest long-term remission rates of only 20-50%. Medications also have common, undesirable side effects that limit acceptability to patients. Benzodiazepines (BZs) are the most effective medication for treating GAD. However, guidelines recommend only prescribing BZs for short-term use due to the potential to develop tolerance and dependence. Neuromodulation investigations via repetitive transcranial magnetic stimulation (rTMS) have recently shown great promise for treating GAD, with responder rates of 64- 100% in short-term studies. However, rTMS is expensive ($6,000-$12,000 for a 20-30 treatment course) and requires daily visits to the clinic, limiting the potential for widespread adoption. Recent preclinical and clinical studies have also shown that acupuncture-based nerve stimulation can be effective for treating anxiety, but it has the key limitation that treatment must be administered by an acupuncturist in the clinic or at home. To build on this work and address the need for a comprehensive therapy for GAD, TheraNova has developed the Empower Neuromodulation System, a portable, non-invasive transcutaneous electrical nerve stimulation (TENS), or transcutaneous electroacupuncture, device for non-invasive stimulation of peripheral nerves. The Empower Neuromodulation System consists of standard, inexpensive TENS gel electrodes and a small, battery- powered signal generator. The goal of this proposal is to conduct a pilot clinical study to evaluate the potential of Empower as a treatment for GAD. We will conduct a 6-week, sham-controlled study in 30 participants with GAD. Participants will be randomized (1:1) to the active or sham treatment and self-administer treatment at home for the duration of the study. In this single study, we will evaluate metrics of feasibility (Specific Aim 1) and acceptability (Specific Aim 2). After demonstrating feasibility in Phase I, we will conduct a long-term pivotal clinical trial in Phase II to evaluate the effect of the Empower therapy on GAD remission. This pivotal study will support FDA clearance, enabling commercialization after Phase II.