Cereset Research Exploratory Study

Обзор

The purpose of this study is to evaluate the use of Cereset Research to improve autonomic function in participants with symptoms of stress, anxiety, or insomnia.

Подробное описание

The primary objective of this open label exploratory study is to evaluate the effect of CR to improve autonomic cardiovascular regulation in participants with symptoms of stress, anxiety, or insomnia.

The secondary objective is to evaluate the effect of CR on a variety of self-reported symptom inventories.

Tertiary objectives are to explore the impact of selected medications on outcomes associated with use of CR, the effect size in subgroups of participants who also report specific co-morbid symptoms or conditions of interest, and any unexpected challenges or barriers for working with the same. The latter includes those with TBI, PTSD, hypertension, hot flashes, chronic pain, or prior stroke.

Methods: This will be a single site, open label, pilot clinical trial, enrolling people aged 11 or older, who have self-reported symptoms of stress, anxiety, or insomnia, and meet a threshold score on self-reported inventories. Up to 200 participants will be enrolled. Participants will receive between 4 and 12 sessions of audible tones echoing current brainwave activity (CR). Participants will continue their other current care throughout the study. There will be pre- and post-intervention data collection of physiological outcomes (BP, HR, and measures of autonomic cardiovascular regulation assessed by heart rate variability and baroreflex sensitivity), which will also serve as the primary outcome. Secondary outcomes to be collected include symptom inventories for insomnia (Insomnia Severity Index, ISI; depression (Center for Epidemiological Studies- Depression Scale, CES-D), anxiety (Generalized Anxiety Disorder-7, GAD-7), and stress (Perceived Stress Scale, PSS). Other tertiary measures include traumatic stress (PTSD Checklist for civilians, PCL-C, or military, PCL-M), and overall quality of life (QOLS). Participants who also self-report having specific co-morbid symptoms or conditions of interest may complete additional condition-specific outcome measures. All measures will be collected at an enrollment visit (V1), and the intervention will begin 0-14 days thereafter. Mean contrasts will be used to compare the changes in measures of autonomic cardiovascular regulation from V1 to V3, the primary outcome, as well as for secondary and appropriate tertiary outcomes. Linear mixed models, which can accommodate within-subject correlations due to repeated assessments over time, will be used to generate point estimates for effect size along with 95% confidence intervals.

Вмешательства

• Устройство Active CR
  The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors

Первичные конечные точки

• Change in Heart Rate Variability [Срок оценки: Baseline, and V3 (4-6 weeks after V2)]
• Change in Baroreflex Sensitivity [Срок оценки: Baseline, and V3 (4-6 weeks after V2)]
• Change in Blood Pressure Variability [Срок оценки: Baseline, and V3 (4-6 weeks after V2)]

Вторичные конечные точки (4)

• Change in Insomnia Severity Index (ISI) [Срок оценки: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)]
• Change in Center for Epidemiologic Studies Depression Scale (CES-D) [Срок оценки: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)]
• Change in Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)]
• Change in Perceived Stress Scale (PSS) [Срок оценки: Baseline, V2 (0-14 days after final session), and V3 (4-6 weeks after V2)]

Критерии участия

Критерии включения

• Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached
• Subjects experiencing symptoms of stress, anxiety, or insomnia, who meet threshold scores on one or more self-reported inventories for the same. This includes the Insomnia Severity Index (ISI, ≥ 8), the Perceived Stress Index (PSS, ≥ 14), or the Generalized Anxiety Disorder 7-item (GAD-7, ≥ 5) scale.

Критерии исключения

• Unable, unwilling, or incompetent to provide informed consent/assent.
• Physically unable to come to the study visits, or to sit comfortably in a chair for up to 1.5 hours.
• Severe hearing impairment (because the subject will be using ear buds during CR).
• Weight is over the chair limit (285 pounds).
• Currently in another active intervention research study.
• Prior use of HIRREM, Brainwave Optimization, Cereset, or a wearable configuration of the same (B2, or B2v2) within the last 3 years.
• Prior use of electroconvulsive therapy (ECT).
• Prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, neurofeedback, biofeedback, or deep brain stimulation (DBS) within one month before enrollment.
• Known seizure disorder.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Wake Forest University Health Scienc\ess — Winston-Salem

Публикации

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• Hale TS, Smalley SL, Dang J, Hanada G, Macion J, McCracken JT, McGough JJ, Loo SK. ADHD familial loading and abnormal EEG alpha asymmetry in children with ADHD. J Psychiatr Res. 2010 Jul;44(9):605-15. doi: 10.1016/j.jpsychires.2009.11.012. Epub 2009 Dec 16. PMID 20006344
• Hale TS, Smalley SL, Hanada G, Macion J, McCracken JT, McGough JJ, Loo SK. Atypical alpha asymmetry in adults with ADHD. Neuropsychologia. 2009 Aug;47(10):2082-8. doi: 10.1016/j.neuropsychologia.2009.03.021. Epub 2009 Apr 5. PMID 19467358
• Lazarev VV, Pontes A, Mitrofanov AA, deAzevedo LC. Interhemispheric asymmetry in EEG photic driving coherence in childhood autism. Clin Neurophysiol. 2010 Feb;121(2):145-52. doi: 10.1016/j.clinph.2009.10.010. Epub 2009 Dec 1. PMID 19951847
• Stroganova TA, Nygren G, Tsetlin MM, Posikera IN, Gillberg C, Elam M, Orekhova EV. Abnormal EEG lateralization in boys with autism. Clin Neurophysiol. 2007 Aug;118(8):1842-54. doi: 10.1016/j.clinph.2007.05.005. Epub 2007 Jun 19. PMID 17581774
• Thibodeau R, Jorgensen RS, Kim S. Depression, anxiety, and resting frontal EEG asymmetry: a meta-analytic review. J Abnorm Psychol. 2006 Nov;115(4):715-29. doi: 10.1037/0021-843X.115.4.715. PMID 17100529
• Avram J, Baltes FR, Miclea M, Miu AC. Frontal EEG activation asymmetry reflects cognitive biases in anxiety: evidence from an emotional face Stroop task. Appl Psychophysiol Biofeedback. 2010 Dec;35(4):285-92. doi: 10.1007/s10484-010-9138-6. PMID 20607389
• Spironelli C, Penolazzi B, Angrilli A. Dysfunctional hemispheric asymmetry of theta and beta EEG activity during linguistic tasks in developmental dyslexia. Biol Psychol. 2008 Feb;77(2):123-31. doi: 10.1016/j.biopsycho.2007.09.009. Epub 2007 Oct 2. PMID 17997211

Идентификаторы

NCT: NCT03777267 · IRB00055280

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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