Atypical EEG beta asymmetry in adults with ADHD.
T Sigi Hale, Susan L Smalley, Patricia D Walshaw...
https://pubmed.ncbi.nlm.nih.gov/20705076Actively Recruiting
Phase Not Applicable
Age: 11Years +
All Genders
ID03777267
Cereset Research Exploratory Study to Improve Autonomic Function in People with Stress, Anxiety, or Insomnia
Led by Wake Forest University Health Sciences · Updated on 2026-05-04
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of Cereset Research (CR), a device-based intervention, to improve autonomic cardiovascular regulation in people aged 11 and older who have symptoms of stress, anxiety, or insomnia. This exploratory, open-label study aims to assess how CR affects heart rate variability, baroreflex sensitivity, and blood pressure variability. Secondary goals include evaluating changes in self-reported symptoms such as insomnia, depression, anxiety, and stress, along with exploring impacts in subgroups with other conditions like traumatic brain injury or PTSD. Participants will receive between 4 and 12 sessions of CR, which delivers audible tones echoing brainwave activity through sensors placed on the scalp with eyes closed. The device uses a 64-bit processing system and switches between sensor pairs during sessions to reduce interruptions and session length. This single-arm trial does not use a control group, and participants continue their usual care throughout the study. Participants will be evaluated at enrollment and through follow-up visits up to 4 to 6 weeks after the final session. Assessments include physiological measures such as blood pressure and heart rate variability, plus questionnaires on sleep, mood, anxiety, stress, traumatic stress, and quality of life. Data will be analyzed to measure changes from baseline and to explore effects in participants with coexisting symptoms or conditions. The total study duration for each participant varies depending on the number of sessions and follow-up timing.
CONDITIONS
Brief Title
Cereset Research Exploratory Study
Who Can Participate
Age: 11Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Ability to follow basic instructions and sit still comfortably with sensor leads attached
- Experience symptoms of stress, anxiety, or insomnia
- Meet threshold scores on at least one self-reported inventory: Insomnia Severity Index (≥8), Perceived Stress Scale (≥14), or Generalized Anxiety Disorder-7 (≥5)
You will not qualify if you...
- Unable or unwilling to provide informed consent or assent
- Unable to attend study visits or sit comfortably for up to 1.5 hours
- Severe hearing impairment preventing use of earbuds
- Weight over 285 pounds, exceeding chair limit
- Currently participating in another active intervention study
- Used HIRREM, Brainwave Optimization, Cereset, or similar device within last 3 years
- Previous electroconvulsive therapy (ECT)
- Used TMS, TDCS, alpha stimulation, neurofeedback, biofeedback, or deep brain stimulation within one month before enrollment
- Known seizure disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 0 to 14 days after enrollment
Participants receive between 4 and 12 sessions of audible tones that echo their brainwave activity using the Cereset Research® (CR) system.
4 to 12 sessions
Follow-up
Duration - 4 to 6 weeks
Participants undergo assessments for physiological outcomes and symptom inventories to evaluate changes after the intervention.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Scienc\ess
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
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Research Team
K
Kenzie Brown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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Published Research Related To This Trial
ADHD familial loading and abnormal EEG alpha asymmetry in children with ADHD.
T Sigi Hale, Susan L Smalley, Jeff Dang...
https://pubmed.ncbi.nlm.nih.gov/20006344Atypical alpha asymmetry in adults with ADHD.
T Sigi Hale, Susan L Smalley, Grant Hanada...
https://pubmed.ncbi.nlm.nih.gov/19467358Interhemispheric asymmetry in EEG photic driving coherence in childhood autism.
V V Lazarev, A Pontes, A A Mitrofanov...
https://pubmed.ncbi.nlm.nih.gov/19951847Abnormal EEG lateralization in boys with autism.
Tatiana A Stroganova, Gudrun Nygren, Marina M Tsetlin...
https://pubmed.ncbi.nlm.nih.gov/17581774Depression, anxiety, and resting frontal EEG asymmetry: a meta-analytic review.
Ryan Thibodeau, Randall S Jorgensen, Sangmoon Kim
https://pubmed.ncbi.nlm.nih.gov/17100529Frontal EEG activation asymmetry reflects cognitive biases in anxiety: evidence from an emotional face Stroop task.
Julia Avram, Felicia Rodica Balteş, Mircea Miclea...
https://pubmed.ncbi.nlm.nih.gov/20607389Dysfunctional hemispheric asymmetry of theta and beta EEG activity during linguistic tasks in developmental dyslexia.
Chiara Spironelli, Barbara Penolazzi, Alessandro Angrilli
https://pubmed.ncbi.nlm.nih.gov/17997211Frontal EEG asymmetry and symptom response to cognitive behavioral therapy in patients with social anxiety disorder.
David A Moscovitch, Diane L Santesso, Vladimir Miskovic...
https://pubmed.ncbi.nlm.nih.gov/21571033Disorder specificity despite comorbidity: resting EEG alpha asymmetry in major depressive disorder and post-traumatic stress disorder.
A H Kemp, K Griffiths, K L Felmingham...
https://pubmed.ncbi.nlm.nih.gov/20708650