Clinical trial NCT03935269: Cereset for Caregivers
Official title: Can We Relieve the Stress: Cereset for Caregivers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glioma
Keywords: High-grade glioma
Stress
Caregivers
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* ≥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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Number of Completed Interventions
timeFrame: 10 days
Secondary outcomes:
measure: Incidence of Adverse Events During Cereset Research Office Intervention
timeFrame: 4 months
measure: Caregiver Interview
timeFrame: 4 months
measure: Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: 4 months
measure: Insomnia Severity Index (ISI)
timeFrame: 4 months
measure: Perceived Stress Scale Questionnaire
timeFrame: 4 months
measure: Changes in Heart Rate - FAROS 180 device
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Roy Strowd, MD
role: PRINCIPAL_INVESTIGATOR
References: