Cereset for Caregivers

Glioma Clinical Trial

— CERESET  

Official title:

Can We Relieve the Stress: Cereset for Caregivers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03935269
• Other study ID #: IRB00058097
• Secondary ID: CCCWFU 03618NCI-
• Status: Withdrawn
• Phase: N/A
• Start date: March 2024
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

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:
• Questionnaire administration
Ancillary studies
• Quality of Life Assessment
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4 months
Secondary	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.	4 months
Secondary	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	4 months
Secondary	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	4 months
Secondary	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	4 months
Secondary	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.	4 months