Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT03935269
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
* 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:
NCT03935269
Study Brief:
Protocol Section:
NCT03935269