Current Studies
Cereset Research Exploratory Study – This ongoing open label, pilot clinical trial, is enrolling people aged 11 or older, who have self-reported symptoms of neurological, cardiovascular, and psychophysiological conditions. Secondary outcomes include evaluating the effect of CR for a variety of self-reported symptom inventories and functional measures. Up to 150 participants will be enrolled to gather pilot data that will help inform regarding feasibility, effect size, and dosing to support future cohort-specific randomized trials. Participants will receive between 4 to 12 sessions of audible tones echoing current brainwave activity. Participants will continue their other current care throughout the study.
Remaining slots will focus on participants who are experiencing symptoms of long-COVID, workplace violence, functional movement disorder, health disparities, traumatic brain injury (TBI), and attention-deficit/hyperactivity disorder (ADHD) (NCT03777267).
Cereset Research for Healthcare Workers: Long-Term Follow-Up – This study will randomize up to 90 adult healthcare workers with symptoms of stress. All subjects will receive 4 Cereset Research sessions over two weeks. Participants who complete the 4 sessions will be randomly assigned to either a Long-term Intervention (I) Group OR a Control (C) Group. The Long-term Intervention (I) group will receive 1 Cereset Research session every 6 weeks after the initial 4 session bolus is complete. This study will follow participants for one year (NCT05994261, recruitment is closed, and the study is in the follow up phase).
Cereset Research for Caregivers – This ongoing exploratory study will evaluate the effects of CR in caregivers with symptoms of stress, anxiety, or insomnia. The primary goals are to evaluate whether CR technology 1) improves autonomic function and 2) improves self-reported symptoms of stress, anxiety, or insomnia in caregivers.
The study aims to enroll 20 participants who will be randomized to receive 4 sessions of ambient nature tones with or without added CR tones linked to brainwaves. Participants in both groups will continue other current care through the study. Those randomized to the group receiving ambient nature tones without added CR tones will be offered the opportunity to crossover and receive 4 sessions linked to brainwaves after completion of data collection visits (NCT05209438).
Cereset Research for Unit Performance Improvement – The purpose of this ongoing study is to explore potential effects of CR on individual and team hospital unit performance, as well as evaluate the feasibility of implementing the CR intervention to healthcare units.
After pre-implementation measures are given to entire units, teammates will be offered the opportunity to receive 4 CR sessions over two weeks. Post-implementation measures will be collected, and data will be compared (NCT06378554).
Completed Studies
Cereset Research for Healthcare Workers – This study will enroll up to 166 healthcare workers, age 18 or older, who have symptoms of stress with a goal of 138 to complete the intervention. Participants will be randomly assigned to either an Early Intervention (EI) group which will receive 4 CR sessions of audible tones echoing current brainwave activity, following enrollment, or a Delayed Intervention (DI) group which will continue current care only and will serve as a control group. Participants in both groups will continue their other current care throughout the study. Those assigned to the DI group will be given the chance to crossover and receive 4 CR sessions a few weeks later (NCT04682197).
Randomized Controlled Pilot Trial of Cereset-SOP for Insomnia – This study will enroll up to 24 adults, with a goal of 20 to complete the intervention. The primary objective of this randomized pilot study is to evaluate the effect of 10 sessions of standardized acoustic stimulation linked to brain activity (Cereset-SOP, standard operating procedure), compared to 10 sessions of nonspecific acoustic stimulation not linked to brain activity (randomly generated tones), on symptoms of insomnia. The secondary objective is to evaluate the effectiveness of blinding for the placebo condition and inform future trial planning. Those assigned to the randomly generated tone group will be given the chance to crossover and receive 10 sessions linked to brainwave activity (NCT03607994).
Randomized Controlled Trial of Closed-Loop Allostatic Neurotechnology to Improve Sensory Function and Pain management After Traumatic Brain Injury – This Congressionally Directed Medical Research Programs funded study targeted TBI in the military, enrolling 184 active duty or retired military personnel, or adult family members with persisting post-concussion symptoms after TBI within the prior 10 years. Phase 1 enrolled 104 similar participants and compared 10 sessions of Cereset-SOP (tones linked to brainwaves), delivered over 5 weeks, with a sham condition using random engineered tones. Phase 2 enrolled 80 participants which compared 10 sessions of Cereset-SOP, received over 5 weeks, with 5 sessions of Cereset-CES (cranial electrical stimulation) that also included an extremely low voltage transcranial alternating current stimulation linked to brainwaves (NCT03649958).