Health PersonnelNCT04682197
Cereset Research In Healthcare Workers During COVID-19
A study testing Cereset Research in people with Health Personnel and Stress, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Personnel, Stress, Anxiety
- What is being tested?
- Cereset Research
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employed Healthcare workers aged 18 years and older.
- Ability to comply with basic instructions and be able to sit still, comfortably during sessions.
- Subjects experiencing symptoms of stress who meet threshold scores the Perceived Stress Index (PSS, ≥ 14).
Who cannot join
- Unable, unwilling, or incompetent to provide informed consent/assent.
- Physically unable to come to the study visits, or to sit still, comfortably in a chair for up to 1 hour.
- Severe hearing impairment (because the subject will be using ear buds during CR).
- Weight is over the chair limit (400 pounds).
- Currently enrolled in another active intervention research study.
- Prior use of: HIRREM, HIRREM-SOP, Brainwave Optimization (BWO), Cereset, Cereset Home, or a wearable configuration of the same (B2, or B2v2).
Show all 11Show fewer
- Prior use of: electroconvulsive therapy (ECT), prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, Eye movement desensitization and reprocessing (EMDR), brain spotting, neurofeedback, biofeedback, or deep brain stimulation (DBS) within one month before enrollment.
- Known seizure disorder.
- Thoughts of suicide within the last 3 months.
- Current, significant symptoms of long-COVID.
- Current medical student.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27104
About this study
Official title: Cereset Research To Reduce Stress In Healthcare Workers In The Time Of COVID-19
The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.
Read the detailed description
The primary objective of this study is to evaluate the effect of CR to improve the Perceived Stress Scale (PSS) in healthcare workers with symptoms of stress, compared to waitlist control, at 4-6 weeks post intervention.
Secondary objectives include evaluating the effect of CR on the self-reported measures of sleep and anxiety. Exploratory measure include a variety of symptom inventories (mood, post-traumatic stress, quality of life, social support, and cognitive function), and autonomic cardiovascular regulation (heart rate variability, HRV).
Methods: This will be a single site, open label, randomized, waitlist controlled pilot clinical trial, enrolling adults aged 18 or older, who have self-reported symptoms of stress or anxiety, and meet a threshold score on self-reported inventories. Up to 166 participants will be enrolled in order to have at least 138 to complete the study. 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.
The primary outcome will be interval change in The Perceived Stress Scale (PSS) which assesses the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Secondary outcomes include insomnia (Insomnia Severity Index, ISI) and anxiety (Generalized Anxiety Disorder-7, GAD-7). Exploratory outcomes to be collected include symptom inventories for depression (Center for Epidemiological Studies- Depression Scale, CES-D), traumatic stress (PTSD Checklist for civilians, PCL-C), overall quality of life (QOLS), social support (ISEL-12), the Multiple Ability Self-Report Questionnaire (MASQ) for cognitive function, Fatigue Severity Scale (FSS) for fatigue, and mental health (Depression, Anxiety, and Stress Scale, DASS -21). Details about COVID-19 status, interaction, workplace engagement, healthcare utilization, and exposure will be collected. Pre- and post-intervention data collection of physiological parameters (Heart rate, HR, and measures of autonomic cardiovascular regulation assessed by heart rate variability) will be assessed as exploratory outcomes.
All measures will be collected at an enrollment visit (V1), and participants will be randomly assigned to the EI or DI groups. For those in the EI group, the intervention will begin 0-7 days thereafter. Sessions will be administered over 10 days. Post-intervention data collections will be obtained at 0-7 days (V2) after completion of the intervention, and 4-6 weeks (V3, primary outcome) after the V2. Following V3, those in the DI group will be offered the opportunity to cross over to receive 4 CR sessions and will continue to be followed for data collections at 0-7 days (V4) after completing their sessions, and 4-6 weeks (V5) after V4. Because V4 and V5 are not required, these visits will be exploratory. 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 exploratory 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.
- Conditions
- Health Personnel, Stress, Anxiety, Insomnia, Hyperarousal, Corona Virus Infection
- Being tested
- Cereset Research
- Keywords
- Anxiety, Stress, Insomnia, Cereset Research, Hyperarousal, Brain electrical activity, Autonomic Dysregulation, Neurotechnology, HIRREM, COVID-19, Coronavirus, Allostasis, neuromodulation, acoustic stimulation, COVID, healthcare worker
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Coronavirus Infections, COVID-19, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereset ResearchDevice
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 are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
| Study group | Role | What they receive |
|---|---|---|
| Cereset Research | Active comparator | For this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions. Receives: Device: Cereset Research |
| Continued Current Care | Other | Participants will continue their current care. Receives: Device: Cereset Research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale (PSS)
The Perceived Stress Scale is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale, with answers rated from 0-4, yields scores ranging from 0-40. Higher scores suggest increase perceived stress.
Measured: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
Secondary outcomes (2)
Change in Insomnia Severity Index (ISI)
The severity of insomnia symptoms is measured using the ISI with each data collection visit. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. Higher scores suggest increased insomnia.
Measured: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
Change in Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 is a seven-item screening tool for anxiety, with answer ranging from 0-3, yielding total scores from 0-21. This is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety.
Measured: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start14 Dec 2021
- Primary completion23 Aug 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (68)Papers the sponsor has linked to this study.
- Other trials for Health PersonnelStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This will be a single site, open label, randomized, waitlist controlled pilot clinical trial, enrolling healthcare workers aged 18 or older, who have self-reported symptoms of stress or anxiety, and meet a threshold score on self-reported inventories. Up to 166 participants will be enrolled in order to have at least 138 to complete the study. 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.
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Susanne Marcus Collins Foundation, Inc.
- Responsible party
- Sponsor
- Investigators
- Charles H Tegeler, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682197
- Sponsor's protocol ID
- IRB00066997
- Status last verified
- Jul 2024
- First submitted
- 16 Dec 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hale TS, Smalley SL, Walshaw PD, Hanada G, Macion J, McCracken JT, McGough JJ, Loo SK. Atypical EEG beta asymmetry in adults with ADHD. Neuropsychologia. 2010 Oct;48(12):3532-9. doi: 10.1016/j.neuropsychologia.2010.08.002. Epub 2010 Aug 10.
PubMed 20705076Hale 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.
PubMed 20006344Hale 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.
PubMed 19467358Lazarev 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.
PubMed 19951847Stroganova 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.
PubMed 17581774Thibodeau 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.
PubMed 17100529Avram 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.
PubMed 20607389Spironelli 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.
PubMed 17997211Moscovitch DA, Santesso DL, Miskovic V, McCabe RE, Antony MM, Schmidt LA. Frontal EEG asymmetry and symptom response to cognitive behavioral therapy in patients with social anxiety disorder. Biol Psychol. 2011 Jul;87(3):379-85. doi: 10.1016/j.biopsycho.2011.04.009. Epub 2011 May 13.
PubMed 21571033Kemp AH, Griffiths K, Felmingham KL, Shankman SA, Drinkenburg W, Arns M, Clark CR, Bryant RA. Disorder specificity despite comorbidity: resting EEG alpha asymmetry in major depressive disorder and post-traumatic stress disorder. Biol Psychol. 2010 Oct;85(2):350-4. doi: 10.1016/j.biopsycho.2010.08.001. Epub 2010 Aug 11.
PubMed 20708650Rabe S, Beauducel A, Zollner T, Maercker A, Karl A. Regional brain electrical activity in posttraumatic stress disorder after motor vehicle accident. J Abnorm Psychol. 2006 Nov;115(4):687-98. doi: 10.1037/0021-843X.115.4.687.
PubMed 17100526Metzger LJ, Paige SR, Carson MA, Lasko NB, Paulus LA, Pitman RK, Orr SP. PTSD arousal and depression symptoms associated with increased right-sided parietal EEG asymmetry. J Abnorm Psychol. 2004 May;113(2):324-9. doi: 10.1037/0021-843X.113.2.324.
PubMed 15122952Marzano C, Ferrara M, Sforza E, De Gennaro L. Quantitative electroencephalogram (EEG) in insomnia: a new window on pathophysiological mechanisms. Curr Pharm Des. 2008;14(32):3446-55. doi: 10.2174/138161208786549326.
PubMed 19075720Wolynczyk-Gmaj D, Szelenberger W. Waking EEG in primary insomnia. Acta Neurobiol Exp (Wars). 2011;71(3):387-92. doi: 10.55782/ane-2011-1860.
PubMed 22068747Riemann D, Spiegelhalder K, Feige B, Voderholzer U, Berger M, Perlis M, Nissen C. The hyperarousal model of insomnia: a review of the concept and its evidence. Sleep Med Rev. 2010 Feb;14(1):19-31. doi: 10.1016/j.smrv.2009.04.002. Epub 2009 May 28.
PubMed 19481481
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cereset Research To Reduce Stress In Healthcare Workers In The Time Of COVID-19
- ClinicalTrials.gov ID
- NCT04682197
- Acronym / sponsor ID
- IRB00066997
- Conditions
- Health Personnel, Stress, Anxiety, Insomnia, Hyperarousal, Corona Virus Infection
- Keywords
- Anxiety, Stress, Insomnia, Cereset Research, Hyperarousal, Brain electrical activity, Autonomic Dysregulation, Neurotechnology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- The Susanne Marcus Collins Foundation, Inc.
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Posted 29 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.
Detailed description
The primary objective of this study is to evaluate the effect of CR to improve the Perceived Stress Scale (PSS) in healthcare workers with symptoms of stress, compared to waitlist control, at 4-6 weeks post intervention.
Secondary objectives include evaluating the effect of CR on the self-reported measures of sleep and anxiety. Exploratory measure include a variety of symptom inventories (mood, post-traumatic stress, quality of life, social support, and cognitive function), and autonomic cardiovascular regulation (heart rate variability, HRV).
Methods: This will be a single site, open label, randomized, waitlist controlled pilot clinical trial, enrolling adults aged 18 or older, who have self-reported symptoms of stress or anxiety, and meet a threshold score on self-reported inventories. Up to 166 participants will be enrolled in order to have at least 138 to complete the study. 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.
The primary outcome will be interval change in The Perceived Stress Scale (PSS) which assesses the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Secondary outcomes include insomnia (Insomnia Severity Index, ISI) and anxiety (Generalized Anxiety Disorder-7, GAD-7). Exploratory outcomes to be collected include symptom inventories for depression (Center for Epidemiological Studies- Depression Scale, CES-D), traumatic stress (PTSD Checklist for civilians, PCL-C), overall quality of life (QOLS), social support (ISEL-12), the Multiple Ability Self-Report Questionnaire (MASQ) for cognitive function, Fatigue Severity Scale (FSS) for fatigue, and mental health (Depression, Anxiety, and Stress Scale, DASS -21). Details about COVID-19 status, interaction, workplace engagement, healthcare utilization, and exposure will be collected. Pre- and post-intervention data collection of physiological parameters (Heart rate, HR, and measures of autonomic cardiovascular regulation assessed by heart rate variability) will be assessed as exploratory outcomes.
All measures will be collected at an enrollment visit (V1), and participants will be randomly assigned to the EI or DI groups. For those in the EI group, the intervention will begin 0-7 days thereafter. Sessions will be administered over 10 days. Post-intervention data collections will be obtained at 0-7 days (V2) after completion of the intervention, and 4-6 weeks (V3, primary outcome) after the V2. Following V3, those in the DI group will be offered the opportunity to cross over to receive 4 CR sessions and will continue to be followed for data collections at 0-7 days (V4) after completing their sessions, and 4-6 weeks (V5) after V4. Because V4 and V5 are not required, these visits will be exploratory. 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 exploratory 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a single site, open label, randomized, waitlist controlled pilot clinical trial, enrolling healthcare workers aged 18 or older, who have self-reported symptoms of stress or anxiety, and meet a threshold score on self-reported inventories. Up to 166 participants will be enrolled in order to have at least 138 to complete the study. 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.
| Arm | Type | Receives |
|---|---|---|
| Cereset Research | Active comparator | Device: Cereset ResearchFor this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions. |
| Continued Current Care | Other | Device: Cereset ResearchParticipants will continue their current care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employed Healthcare workers aged 18 years and older.
- Ability to comply with basic instructions and be able to sit still, comfortably during sessions.
- Subjects experiencing symptoms of stress who meet threshold scores the Perceived Stress Index (PSS, ≥ 14).
Key exclusion criteria (11 listed)
- Unable, unwilling, or incompetent to provide informed consent/assent.
- Physically unable to come to the study visits, or to sit still, comfortably in a chair for up to 1 hour.
- Severe hearing impairment (because the subject will be using ear buds during CR).
- Weight is over the chair limit (400 pounds).
- Currently enrolled in another active intervention research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cereset ResearchThe 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 are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions. | Device | Cereset Research, Continued Current Care |
Primary outcome
Change in Perceived Stress Scale (PSS)
Time frame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
The Perceived Stress Scale is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale, with answers rated from 0-4, yields scores ranging from 0-40. Higher scores suggest increase perceived stress.
2 secondary outcomes
Change in Insomnia Severity Index (ISI)
Time frame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20705076Hale TS, Smalley SL, Walshaw PD, Hanada G, Macion J, McCracken JT, McGough JJ, Loo SK. Atypical EEG beta asymmetry in adults with ADHD. Neuropsychologia. 2010 Oct;48(12):3532-9. doi: 10.1016/j.neuropsychologia.2010.08.002. Epub 2010 Aug 10.
- Background: PubMed 20006344Hale 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.
- Background: PubMed 19467358Hale 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.
- Background: PubMed 19951847Lazarev 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.
- Background: PubMed 17581774Stroganova 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.
- Background: PubMed 17100529Thibodeau 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.
- Background: PubMed 20607389Avram 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.
- Background: PubMed 17997211Spironelli 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.
- Background: PubMed 21571033Moscovitch DA, Santesso DL, Miskovic V, McCabe RE, Antony MM, Schmidt LA. Frontal EEG asymmetry and symptom response to cognitive behavioral therapy in patients with social anxiety disorder. Biol Psychol. 2011 Jul;87(3):379-85. doi: 10.1016/j.biopsycho.2011.04.009. Epub 2011 May 13.
- Background: PubMed 20708650Kemp AH, Griffiths K, Felmingham KL, Shankman SA, Drinkenburg W, Arns M, Clark CR, Bryant RA. Disorder specificity despite comorbidity: resting EEG alpha asymmetry in major depressive disorder and post-traumatic stress disorder. Biol Psychol. 2010 Oct;85(2):350-4. doi: 10.1016/j.biopsycho.2010.08.001. Epub 2010 Aug 11.
- Background: PubMed 17100526Rabe S, Beauducel A, Zollner T, Maercker A, Karl A. Regional brain electrical activity in posttraumatic stress disorder after motor vehicle accident. J Abnorm Psychol. 2006 Nov;115(4):687-98. doi: 10.1037/0021-843X.115.4.687.
- Background: PubMed 15122952Metzger LJ, Paige SR, Carson MA, Lasko NB, Paulus LA, Pitman RK, Orr SP. PTSD arousal and depression symptoms associated with increased right-sided parietal EEG asymmetry. J Abnorm Psychol. 2004 May;113(2):324-9. doi: 10.1037/0021-843X.113.2.324.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles H Tegeler, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cereset Research in people with Health Personnel and Stress, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale (PSS) (time frame: Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682197, which also lists 68 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.