Clinical trial · Interventional
Cereset for Caregivers
Can We Relieve the Stress: Cereset for Caregivers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No accruals, DSMB/PRC closed study
Summary
Brief summary (as posted)
In this single arm, open label study, investigators will evaluate the feasibility of using the Cereset (formerly known as HIRREM - high-resolution relational, resonance-based electroencephalic mirroring) intervention for a stressed population confronting an acute burden on their lives - caregivers of newly diagnosed high-grade glioma patients. The Cereset intervention is a closed-loop acoustic stimulation intervention that has been studied in patients with PTSD, insomnia, postural orthostatic tachycardia, and military veterans.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cereset Research Wearable | Device | — | UNRESOLVED |
| Quality of Life Assessment | Other | — | UNRESOLVED |
| Questionnaire administration | Other | — | UNRESOLVED |
| Stress management therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention with Ambulatory Therapy
- description
- Caregivers of participants with high-grade glioma will undergo standard Cereset Research Office (CRO) in-office treatment for a total of five (5) treatments. Ambulatory therapy with the Cereset Research Wearable (CRW) will be available to caregivers while they are attending routine radiation therapy with glioma patients.
- interventionNames
- Device: Cereset Research Wearable
- Procedure: Stress management therapy
- Other: Questionnaire administration
- Other: Quality of Life Assessment
Primary outcomes (1)
- measure
- Number of Completed Interventions
- timeFrame
- 10 days
- description
- Intervention feasibility will be the number of trial participants who complete the Cereset Research Office intervention (5 out of 5 prescribed sessions).
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available