Cereset for Caregivers (CERESET)

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Glioma

Treatments: Other: Quality of Life Assessment; Procedure: Stress management therapy; Device: Cereset Research Wearable; Other: Questionnaire administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03935269

IRB00058097

CCCWFU 03618 (Other Identifier)

NCI-2019-02840 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Primary Objective:

• To determine the feasibility of completing the prescribed Cereset Research Office intervention for trial participants in this single arm, open label study.

Secondary Objectives

• To assess the tolerability of the intervention
• To assess changes in trial participant wellbeing and quality of life.
• To assess changes in physiological response at pre-intervention and post-intervention time points.

Exploratory Objectives

• To assess the utilization of Cereset Research Wearable (portable, limited scope wearable device) after the CRO intervention.
• To assess the participant acceptability of the Cereset Research Intervention.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Intervention with Ambulatory Therapy

Experimental group

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.

Treatment:

Procedure: Stress management therapy

Other: Questionnaire administration

Device: Cereset Research Wearable

Other: Quality of Life Assessment