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New treatment option for Neurological Diseases or Conditions
Official title Cereset Research Exploratory Study
ClinicalTrials.gov ID: NCT03777267
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 11 and older
You may be able to join if
- people must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached
- people experiencing symptoms of stress, anxiety, or insomnia, who meet threshold scores on one or more self-reported inventories for the same. This...
You likely can't join if
- 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.
See the full eligibility criteria
- people must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached
- people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 11 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.