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出境医 / 临床实验 / Cereset for Caregivers (CERESET)

Cereset for Caregivers (CERESET)

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.

Condition or disease Intervention/treatment Phase
Glioma Device: Cereset Research Wearable Procedure: Stress management therapy Other: Questionnaire administration Other: Quality of Life Assessment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Can We Relieve the Stress: Cereset for Caregivers
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Arm Intervention/treatment
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.
Device: Cereset Research Wearable
Cereset Research Wearable is a portable, wearable

Procedure: Stress management therapy
Undergo Cereset research office intervention

Other: Questionnaire administration
Ancillary studies

Other: Quality of Life Assessment
Ancillary studies

Outcome Measures
Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Incidence of Adverse Events During Cereset Research Office Intervention [ Time Frame: 4 months ]
    Tolerability will be determined with adverse event 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).

  2. Incidence of Adverse Events During Cereset Research Wearable [ Time Frame: 4 months ]
    Tolerability will be determined with adverse event monitoring and assessment of adverse events bi-weekly during Cereset Research Wearable 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).

  3. 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).

  4. 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.

  5. 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).

  6. 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.

  7. Collection of Biometric (BIOPAC) Data - Blood Pressure [ Time Frame: 4 months ]
    Continuous readings of systolic blood pressures will be acquired from finger arterial pressure measurements for a minimum of 10 minutes for physiologic changes in heart rate variability and baroreflex sensitivity at pre-intervention (B1) and during, and post-intervention time points (B2, B3). The recordings of systolic blood pressures will be analyzed for calculation of multiple standard measures of HRV including the standard deviation of normal to normal intervals (SDNN), and the root mean square of successive beat-to-beat differences in R-R interval duration (rMSSD).

  8. Collection of Biometric (BIOPAC) Data - Heart Rate [ Time Frame: 4 months ]
    Continuous readings of heart rate will be acquired from electrocardiogram for a minimum of 10 minutes for physiologic changes in heart rate variability and baroreflex sensitivity at pre-intervention (B1) and during, and post-intervention time points (B2, B3). The recordings of heart rate will be analyzed for calculation of multiple standard measures of heart rate variability including the standard deviation of normal to normal intervals (SDNN), and the root mean square of successive beat-to-beat differences in R-R interval duration (rMSSD) .


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥18 years of age
  • Identified as caregiver by patient with high grade 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
  • World Health Organization (WHO) grade IV glioma
  • WHO grade III glioma
  • WHO grade II glioma, isocitrate dehydrogenase wildtype (molecular glioblastoma multiforme)
  • Patient with high grade glioma who are planning or are in the process of receiving at least >20 fractions of radiation therapy delivered at Wake Forest Baptist Medical Center Department of Radiation Oncology in Winston-Salem, NC.
  • Trial participant is able to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
  • Trial participant is able to sit in a chair for 90 minutes.

Exclusion Criteria:

  • 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.
  • Participant is caring for a patient who has previously completed 50% or more of adjuvant radiation therapy for high grade glioma defined as 50% or more of the total prescribed fractions delivered.
  • Participant has severe hearing impairment defined as word discrimination at <50% with or without the use of hearing aids.
  • Participant's weight is greater than or equal to 285 pounds at time of enrollment (chair limit).
  • Prior 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.
  • Participant has previously used HIRREM, or Cereset.
  • Participant has a known seizure disorder requiring ongoing anti-epileptics prescribed specifically for seizure disorder.
  • Participant states he or she will not be able to abstain from daily use of alcohol or recreational drugs during the intervention period.
Contacts and Locations

Contacts
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Contact: Study Nurse 336-716-5440 arcarrol@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Contact: Study Nurse         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Roy Strowd, MD Wake Forest University Health Sciences
Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date May 17, 2021
Estimated Study Start Date  ICMJE July 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Incidence of Adverse Events During Cereset Research Office Intervention [ Time Frame: 4 months ]
    Tolerability will be determined with adverse event 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).
  • Incidence of Adverse Events During Cereset Research Wearable [ Time Frame: 4 months ]
    Tolerability will be determined with adverse event monitoring and assessment of adverse events bi-weekly during Cereset Research Wearable 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).
  • 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).
  • 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.
  • 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).
  • 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.
  • Collection of Biometric (BIOPAC) Data - Blood Pressure [ Time Frame: 4 months ]
    Continuous readings of systolic blood pressures will be acquired from finger arterial pressure measurements for a minimum of 10 minutes for physiologic changes in heart rate variability and baroreflex sensitivity at pre-intervention (B1) and during, and post-intervention time points (B2, B3). The recordings of systolic blood pressures will be analyzed for calculation of multiple standard measures of HRV including the standard deviation of normal to normal intervals (SDNN), and the root mean square of successive beat-to-beat differences in R-R interval duration (rMSSD).
  • Collection of Biometric (BIOPAC) Data - Heart Rate [ Time Frame: 4 months ]
    Continuous readings of heart rate will be acquired from electrocardiogram for a minimum of 10 minutes for physiologic changes in heart rate variability and baroreflex sensitivity at pre-intervention (B1) and during, and post-intervention time points (B2, B3). The recordings of heart rate will be analyzed for calculation of multiple standard measures of heart rate variability including the standard deviation of normal to normal intervals (SDNN), and the root mean square of successive beat-to-beat differences in R-R interval duration (rMSSD) .
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cereset for Caregivers
Official Title  ICMJE Can We Relieve the Stress: Cereset for Caregivers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Glioma
Intervention  ICMJE
  • Device: Cereset Research Wearable
    Cereset Research Wearable is a portable, wearable
  • Procedure: Stress management therapy
    Undergo Cereset research office intervention
  • Other: Questionnaire administration
    Ancillary studies
  • Other: Quality of Life Assessment
    Ancillary studies
Study Arms  ICMJE 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.
Interventions:
  • Device: Cereset Research Wearable
  • Procedure: Stress management therapy
  • Other: Questionnaire administration
  • Other: Quality of Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 30, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥18 years of age
  • Identified as caregiver by patient with high grade 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
  • World Health Organization (WHO) grade IV glioma
  • WHO grade III glioma
  • WHO grade II glioma, isocitrate dehydrogenase wildtype (molecular glioblastoma multiforme)
  • Patient with high grade glioma who are planning or are in the process of receiving at least >20 fractions of radiation therapy delivered at Wake Forest Baptist Medical Center Department of Radiation Oncology in Winston-Salem, NC.
  • Trial participant is able to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
  • Trial participant is able to sit in a chair for 90 minutes.

Exclusion Criteria:

  • 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.
  • Participant is caring for a patient who has previously completed 50% or more of adjuvant radiation therapy for high grade glioma defined as 50% or more of the total prescribed fractions delivered.
  • Participant has severe hearing impairment defined as word discrimination at <50% with or without the use of hearing aids.
  • Participant's weight is greater than or equal to 285 pounds at time of enrollment (chair limit).
  • Prior 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.
  • Participant has previously used HIRREM, or Cereset.
  • Participant has a known seizure disorder requiring ongoing anti-epileptics prescribed specifically for seizure disorder.
  • Participant states he or she will not be able to abstain from daily use of alcohol or recreational drugs during the intervention period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Study Nurse 336-716-5440 arcarrol@wakehealth.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03935269
Other Study ID Numbers  ICMJE IRB00058097
CCCWFU 03618 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
NCI-2019-02840 ( Other Identifier: Clinical Trials Reporting Program )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roy Strowd, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP