ABSTRACT
Persistent symptoms after mild traumatic brain injury (mTBI), including chronic pain and sensory disturbance, may be related to alterations at the level of neural oscillations. Studies in mTBI patients show disturbed sleep as a core component of symptoms. The purpose of this study is to evaluate a noninvasive, closed-loop, acoustic stimulation neurotechnology (HIRREM-SOP called Cereset Research, using non-invasive BrainEcho technology) as a novel treatment to enable both physiological and clinical recovery from mTBI, through auto-calibration of neural oscillations. The study is conducted as a single blind study at two sites USUHS/Walter Reed and WAMC. The hypothesis is that usage of Cereset Research neurotechnology (ten sessions, 90 minutes each), will entail greater reduction in persistent symptoms of mTBI, at three months, than exposure to non-specific random tones that are delivered in a comparable way. The participant enrollment has begun at both USUHS/Walter Reed and WAMC. Both sites progressed nicely until March of 2020 when COVID forced a complete shutdown of research interventions. IRB permissions were granted for the sites to do follow-up visits remotely, but no new clients were allowed to be enrolled or begin the intervention process. COVID restrictions have recently been lifted so the sites can again begin to advertise and enroll new participants. COVID caused this study to be delayed at least 4 to 6 months.
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.