Cereset for Caregivers

NCT03935269 | Withdrawn DMC FDA Device

• 3 other identifiers: IRB00058097CCCWFU 03618NCI-2019-02840
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Glioma

Keywords

High-grade glioma; Stress; Caregivers

Outcome Measures

Primary Outcomes (1)

• Number of Completed Interventions

  Intervention feasibility will be the number of trial participants who complete the Cereset Research Office intervention (5 out of 5 prescribed sessions).

  10 days

Secondary Outcomes (6)

• Incidence of Adverse Events During Cereset Research Office Intervention

  4 months

• Caregiver Interview

  4 months

• Generalized Anxiety Disorder 7-item scale (GAD-7)

  4 months

• Insomnia Severity Index (ISI)

  4 months

• Perceived Stress Scale Questionnaire

  4 months

Study Arms (1)

Intervention with Ambulatory Therapy

EXPERIMENTAL

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.

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

Interventions

Cereset Research Wearable DEVICE

CRW is a stress-relaxation device where participants listen to sounds that help to balance brain rhythms. Participants will be asked to come to an office for 5 days over 1-2 weeks, on your their schedule. Sessions will take approximately one (1) hour to complete.

Intervention with Ambulatory Therapy

Stress management therapy PROCEDURE

Undergo Cereset research office intervention

Intervention with Ambulatory Therapy

Questionnaire administration OTHER

Ancillary studies

Intervention with Ambulatory Therapy

Quality of Life Assessment OTHER

Ancillary studies

Intervention with Ambulatory Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Roy Strowd, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 2, 2019
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share