Exploratory study of acoustic neuromodulation improves pain, autonomic function, and symptoms of insomnia, stress, and anxiety in individuals with chronic pain

ABSTRACT

Objective: Evaluate the impact of Cereset Research™ (CR), on pain, autonomic function, insomnia, stress, and anxiety for those with chronic pain. Background: Chronic pain is a worldwide crisis causing negative health outcomes, and risk for psychological disorders. Effective non-drug, noninvasive, cost-effective, durable modalities are lacking. CR is a noninvasive, closed-loop, acoustic neuromodulation technology, echoing brainwaves in real time as auditory tones. Design/Methods: 19 adults (10 females, median age 48) with chronic pain (median 5 years), and insomnia (ISI, of ≥8 points for ≥1 month), stress (PSS of ≥14), or anxiety (GAD-7 of ≥5), enrolled in this exploratory trial. Subjects received 6-12, sixty-minute sessions of tones linked to brainwaves plus continued current care. Data was collected at baseline (V1), 0-21 days (V2) after intervention, 4-7 weeks after V2 (V3), and 4-7 weeks after V3 (V4). HRV (SDNN and rMSSD) was obtained as primary outcome based on 10-minute BP and HR recordings using a continuous non-invasive blood pressure system, with change in ISI, PSS, GAD-7, CES-D, PCL-C, and MPQ as secondary outcomes. We report interim results for symptom and HRV outcomes across visits. Results: 19 subjects completed V1-V2 measures. Due to COVID-19, V1-V4=10. Median change V1 to V4 ISI-6.5 (p=0.001);PSS score-5.5 (p<0.01);GAD-7-6 (p<0.01), CES-D-7 (p<0.01);and PCL-C-8 (p<0.01);MPQ-8.5 (p=0.52). Mean (median) SDNN and rMSSD significantly increased by 45.7 % (30.9%) and 89.1% (47.1%) respectively from V1 to V2. SDNN improved from V1 to V4 36.6% (39.0%), p=0.02. Conclusions: Interim results suggest significant, durable reductions in self-reported scores for insomnia, anxiety, depression, post-traumatic stress, and pain in those with chronic pain. In this small cohort, many reductions were clinically meaningful and there were also trends for improved HRV. Further evaluation is needed for this scalable, non-drug intervention.