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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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03935269
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Withdrawn
Phase N/A
Start date March 2024
Completion date September 2024

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