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Cereset for Caregivers (CERESET)

Primary Purpose

Glioma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cereset Research Wearable
Stress management therapy
Questionnaire administration
Quality of Life Assessment
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glioma focused on measuring High-grade glioma, Stress, Caregivers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Wake Forest Baptist Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention with Ambulatory Therapy

Arm 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Incidence of Adverse Events During Cereset Research Office Intervention
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.
Caregiver Interview
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.
Generalized Anxiety Disorder 7-item scale (GAD-7)
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
Insomnia Severity Index (ISI)
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
Perceived Stress Scale Questionnaire
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
Changes in Heart Rate - FAROS 180 device
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.

Full Information

First Posted
April 25, 2019
Last Updated
October 24, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03935269
Brief Title
Cereset for Caregivers
Acronym
CERESET
Official Title
Can We Relieve the Stress: Cereset for Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2024 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
High-grade glioma, Stress, Caregivers

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention with Ambulatory Therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Cereset Research Wearable
Intervention Description
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 Type
Procedure
Intervention Name(s)
Stress management therapy
Intervention Description
Undergo Cereset research office intervention
Intervention Type
Other
Intervention Name(s)
Questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Number of Completed Interventions
Description
Intervention feasibility will be the number of trial participants who complete the Cereset Research Office intervention (5 out of 5 prescribed sessions).
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Incidence of Adverse Events During Cereset Research Office Intervention
Description
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.
Time Frame
4 months
Title
Caregiver Interview
Description
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.
Time Frame
4 months
Title
Generalized Anxiety Disorder 7-item scale (GAD-7)
Description
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
Time Frame
4 months
Title
Insomnia Severity Index (ISI)
Description
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
Time Frame
4 months
Title
Perceived Stress Scale Questionnaire
Description
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
Time Frame
4 months
Title
Changes in Heart Rate - FAROS 180 device
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Nurse
Phone
336-716-5440
Email
arcarrol@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Strowd, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Nurse

12. IPD Sharing Statement

Plan to Share IPD
No

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