Cereset for Caregivers (CERESET)

March 18, 2024 updated by: Wake Forest University Health Sciences

Can We Relieve the Stress: Cereset for Caregivers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Comprehensive Cancer Center
        • Contact:
          • Study Nurse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention with Ambulatory Therapy
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.
Other: Questionnaire administration
Ancillary studies
Device: Cereset Research Wearable
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.
Procedure: Stress management therapy
Undergo Cereset research office intervention
Other: Quality of Life Assessment
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Completed Interventions
Time Frame: 10 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events During Cereset Research Office Intervention
Time Frame: 4 months
Tolerability will be reported as the total number, grade, time from enrollment and time to resolution of CTCAE and adverse event detected by investigator monitoring and assessment of adverse events at visits 1, 2, 3, and 4 during Cereset Research Office Intervention using the CTCAE 5.0 (Grade 1-5, 1 = mild, 5 = death). Adverse events will be divided into four categories (common adverse events >15-20%, uncommon adverse events <15%, rare but potentially serious adverse events and unexpected toxicities). Any Grade 3 toxicity by CTCAE will be further evaluated as an unacceptable event.
4 months
Caregiver Interview
Time Frame: 4 months
Caregiver interview is a 21-item questionnaire that contains things a person might do when caring for a loved one with cancer. Scores ranges from 1-9 ('1' would state that the participant is not-at-all confident to accomplish the listed behavior; '9' would state that the participant is totally confident to accomplish the listed behavior. Numbers in the middle of the scale indicate that the participant is moderately confident to accomplish the listed behavior). Mean core values for each survey will be calculated for all participants enrolled. Surveys will be provided to participants pre- and post-intervention. Paired student's t-test will be used to compare scores at these V1, V2, V3, V4 time points.
4 months
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time Frame: 4 months
The Generalized Anxiety Disorder-7 is a validated, short seven item scale. Response scale = (not at all sure = 0; several days = 1; over half the days = 2; to nearly every day = 3). Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. Mean core values for each survey will be calculated for all participants enrolled. Surveys will be provided to participants pre- and post-intervention. Paired student's t-test will be used to compare scores at these V1, V2, V3, V4 time points
4 months
Insomnia Severity Index (ISI)
Time Frame: 4 months
The Insomnia Severity Index is a validated, 7 item self-report questionnaire assessing the nature, severity, and impact of insomnia in the past month. Rating scale (0 = very satisfied to 4 = very dissatisfied; 0 = not at all noticeable to 4 = very much noticeable; 0 = not at all worried to 4 = very much worried; 0 = not at all interfering to 4 = very much interfering). Mean core values for each survey will be calculated for all participants enrolled. Surveys will be provided to participants pre- and post-intervention. Paired student's t-test will be used to compare scores at these V1, V2, V3, V4 time points
4 months
Perceived Stress Scale Questionnaire
Time Frame: 4 months
The Perceived Stress Scale (PSS) is a 10-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Scale range is 0 = never, 4 = very often. Mean core values for each survey will be calculated for all participants enrolled. Surveys will be provided to participants pre- and post-intervention. Paired student's t-test will be used to compare scores at these V1, V2, V3, V4 time points
4 months
Changes in Heart Rate - FAROS 180 device
Time Frame: 4 months
Continuous readings of heart rate will be acquired using FAROS 180 heart rate monitor for a minimum of 10 minutes for physiologic changes in heart rate at pre-intervention (B1) and during, and post-intervention time points (B2, B3, B4). The mean values of HRV will be compared with paired student's t-test.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roy Strowd, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00058097
  • CCCWFU 03618 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)
  • NCI-2019-02840 (Other Identifier: Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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