Condition or disease | Intervention/treatment | Phase |
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Glioma | Device: Cereset Research Wearable Procedure: Stress management therapy Other: Questionnaire administration Other: Quality of Life Assessment | Not Applicable |
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
Exploratory Objectives
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 |
Arm | Intervention/treatment |
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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.
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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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Study Nurse | 336-716-5440 | arcarrol@wakehealth.edu |
United States, North Carolina | |
Wake Forest Baptist Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: Study Nurse |
Principal Investigator: | Roy Strowd, MD | Wake Forest University Health Sciences |
Tracking Information | |||||||||
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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 |
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).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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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
Exploratory Objectives
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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 |
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Condition ICMJE | Glioma | ||||||||
Intervention ICMJE |
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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:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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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 ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Wake Forest University Health Sciences | ||||||||
Study Sponsor ICMJE | Wake Forest University Health Sciences | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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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 |