| 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 |
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 |
|---|---|
|
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
|
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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
|
||||||||
| 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 |
|
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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 |
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