Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT03935269
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years of age
* Identified as caregiver by patient with glioma as defined as the primary, non-professional, non-paid person who provides the majority of emotional financial and/or physical support. There will only be one trial participant allowed per patient/caregiver dyad.
* The trial participant must be caring for a patient who is:
* ≥18 years of age
* Has a histologically confirmed malignancy that is a high grade glioma which includes (astrocytoma, oligodendroglioma, glioblastoma, ependymoma).
* Any World Health Organization (WHO) grade gliomas
* Trial participant is able to understand and the willingness to sign an IRB-approved informed consent document.
* Trial participant is able to sit in a chair for 90 minutes.
Exclusion Criteria:
* Trial participant is a heavy alcohol user per the Substance Abuse and Mental Health Services Administration.
* Heavy alcohol use is defined as binge drinking on 5 or more days in the past month.
* Binge drinking is defined as 4 drinks for women and 5 drinks for men on the same occasion.
* Trial participant has severe hearing impairment defined as word discrimination at \<50% with or without the use of hearing aids.
* Trial participant's weight is greater than or equal to 400 pounds at time of enrollment (chair limit).
* Prior trial participant 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.
* Trial participant has previously used HIRREM, or Cereset.
* Trial participant has a known seizure disorder requiring ongoing anti-epileptics prescribed specifically for seizure disorder.
* Trial participant states he or she will not be able to abstain from daily use of alcohol or recreational drugs during the intervention period.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03935269
Study Brief:
Protocol Section:
NCT03935269