GliomaCERESETNCT03935269
Cereset for Caregivers
A study testing Cereset Research Wearable, Stress management therapy and Questionnaire administration in people with Glioma, run by Wake Forest University Health Sciences.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glioma
- What is being tested?
- Cereset Research Wearable, Stress management therapy and Questionnaire administration
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Glioma
- Being tested
- Cereset Research Wearable, Stress management therapy, Questionnaire administration, Quality of Life Assessment
- Keywords
- High-grade glioma, Stress, Caregivers
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereset Research WearableDevice
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.
Stress management therapyProcedure or surgery
Undergo Cereset research office intervention
Questionnaire administrationOther
Ancillary studies
Quality of Life AssessmentOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Intervention with Ambulatory Therapy | Experimental | 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. Receives: Device: Cereset Research Wearable; Procedure: Stress management therapy; Other: Questionnaire administration; Other: Quality of Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 days
Secondary outcomes (6)
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.
Measured: 4 months
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.
Measured: 4 months
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
Measured: 4 months
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
Measured: 4 months
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
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study startMar 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: No accruals, DSMB/PRC closed study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roy Strowd, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935269
- Sponsor's protocol ID
- IRB00058097
- Other IDs
- CCCWFU 03618, NCI-2019-02840
- Acronym
- CERESET
- Status last verified
- Mar 2024
- First submitted
- 25 Apr 2019
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can We Relieve the Stress: Cereset for Caregivers
- ClinicalTrials.gov ID
- NCT03935269
- Acronym / sponsor ID
- CERESET / IRB00058097
- Conditions
- Glioma
- Keywords
- High-grade glioma, Stress, Caregivers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accruals, DSMB/PRC closed study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention with Ambulatory Therapy | Experimental | Device: Cereset Research Wearable, Procedure: Stress management therapy, Other: Questionnaire administration, Other: Quality of Life AssessmentCaregivers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥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).
Key exclusion criteria (9 listed)
- Trial participant is a heavy alcohol user per the Substance Abuse and Mental Health Services Administration.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cereset Research WearableCRW 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. | Device | Intervention with Ambulatory Therapy |
| Stress management therapyUndergo Cereset research office intervention | Procedure or surgery | Intervention with Ambulatory Therapy |
| Questionnaire administrationAncillary studies | Other | Intervention with Ambulatory Therapy |
| Quality of Life AssessmentAncillary studies | Other | Intervention with Ambulatory Therapy |
Primary outcome
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).
6 secondary outcomes
Incidence of Adverse Events During Cereset Research Office Intervention
Time frame: 4 months
Caregiver Interview
Time frame: 4 months
Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: 4 months
Insomnia Severity Index (ISI)
Time frame: 4 months
Perceived Stress Scale Questionnaire
Time frame: 4 months
Changes in Heart Rate - FAROS 180 device
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Glioma
Active, not recruitingPhase 1/2
Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma
Glioblastoma, Gliosarcoma
RecruitingPhase 2
Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas
BRAF V600 Mutation, Low-grade Glioma
RecruitingPhase 2
Temozolomide, With or Without WSD0922-FU, for the Treatment of EGFR-Mutant, IDH-Wildtype Glioblastoma
Glioblastoma, IDH-Wildtype
Active, not recruitingPhase 1
Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma
Glioblastoma
Active, not recruitingPhase 2
A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden
Astrocytoma, IDH-Mutant, Grade 4, Diffuse Glioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Strowd, MD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Cereset Research Wearable, Stress management therapy and Questionnaire administration in people with Glioma, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Completed Interventions (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.