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Cereset for Caregivers

Studies

Study First Submitted Date 2019-04-25
Study First Posted Date 2019-05-02
Last Update Posted Date 2023-03-28
Start Month Year February 2024
Primary Completion Month Year September 2024
Verification Month Year March 2023
Verification Date 2023-03-31
Last Update Posted Date 2023-03-28

Detailed Descriptions

Sequence: 20671959
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.

Facilities

Sequence: 199548335
Status Recruiting
Name Wake Forest Baptist Comprehensive Cancer Center
City Winston-Salem
State North Carolina
Zip 27157
Country United States

Facility Contacts

Sequence: 28052548
Facility Id 199548335
Contact Type primary
Name Study Nurse

Conditions

Sequence: 52041587
Name Glioma
Downcase Name glioma

Id Information

Sequence: 40056357 Sequence: 40056358 Sequence: 40056359
Id Source org_study_id Id Source secondary_id Id Source secondary_id
Id Value IRB00058097 Id Value CCCWFU 03618 Id Value NCI-2019-02840
Id Type Other Identifier Id Type Other Identifier
Id Type Description Wake Forest Baptist Comprehensive Cancer Center Id Type Description Clinical Trials Reporting Program

Countries

Sequence: 42454538
Name United States
Removed False

Design Groups

Sequence: 55449973
Group Type Experimental
Title 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.

Interventions

Sequence: 52353244 Sequence: 52353245 Sequence: 52353246 Sequence: 52353247
Intervention Type Device Intervention Type Procedure Intervention Type Other Intervention Type Other
Name Cereset Research Wearable Name Stress management therapy Name Questionnaire administration Name Quality of Life Assessment
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. Description Undergo Cereset research office intervention Description Ancillary studies Description Ancillary studies

Keywords

Sequence: 79657556 Sequence: 79657557 Sequence: 79657558
Name High-grade glioma Name Stress Name Caregivers
Downcase Name high-grade glioma Downcase Name stress Downcase Name caregivers

Design Outcomes

Sequence: 176930094 Sequence: 176930095 Sequence: 176930096 Sequence: 176930097 Sequence: 176930098 Sequence: 176930099 Sequence: 176930100
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Number of Completed Interventions Measure Incidence of Adverse Events During Cereset Research Office Intervention Measure Caregiver Interview Measure Generalized Anxiety Disorder 7-item scale (GAD-7) Measure Insomnia Severity Index (ISI) Measure Perceived Stress Scale Questionnaire Measure Changes in Heart Rate – FAROS 180 device
Time Frame 10 days Time Frame 4 months Time Frame 4 months Time Frame 4 months Time Frame 4 months Time Frame 4 months Time Frame 4 months
Description Intervention feasibility will be the number of trial participants who complete the Cereset Research Office intervention (5 out of 5 prescribed sessions). 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. 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. 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 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 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 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.

Browse Conditions

Sequence: 192969431 Sequence: 192969432 Sequence: 192969433 Sequence: 192969434 Sequence: 192969435 Sequence: 192969436 Sequence: 192969437 Sequence: 192969438
Mesh Term Glioma Mesh Term Neoplasms, Neuroepithelial Mesh Term Neuroectodermal Tumors Mesh Term Neoplasms, Germ Cell and Embryonal Mesh Term Neoplasms by Histologic Type Mesh Term Neoplasms Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms, Nerve Tissue
Downcase Mesh Term glioma Downcase Mesh Term neoplasms, neuroepithelial Downcase Mesh Term neuroectodermal tumors Downcase Mesh Term neoplasms, germ cell and embryonal Downcase Mesh Term neoplasms by histologic type Downcase Mesh Term neoplasms Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms, nerve tissue
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48197512
Agency Class OTHER
Lead Or Collaborator lead
Name Wake Forest University Health Sciences

Overall Officials

Sequence: 29209605
Role Principal Investigator
Name Roy Strowd, MD
Affiliation Wake Forest University Health Sciences

Central Contacts

Sequence: 11981286
Contact Type primary
Name Study Nurse
Phone 336-716-5440
Email arcarrol@wakehealth.edu
Role Contact

Design Group Interventions

Sequence: 67975833 Sequence: 67975834 Sequence: 67975835 Sequence: 67975836
Design Group Id 55449973 Design Group Id 55449973 Design Group Id 55449973 Design Group Id 55449973
Intervention Id 52353244 Intervention Id 52353245 Intervention Id 52353246 Intervention Id 52353247

Eligibilities

Sequence: 30688940
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
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.

Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253897122
Number Of Facilities 1
Registered In Calendar Year 2019
Were Results Reported False
Has Us Facility True
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 6

Designs

Sequence: 30435637
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28802157
Responsible Party Type Sponsor