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Behavioural Intervention
Cereset for Caregiver Stress (CERESET Trial)
N/A
Waitlist Available
Led By Roy Strowd, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
CERESET Trial Summary
This trial will study whether the Cereset intervention can help caregivers of newly diagnosed high-grade glioma patients who are under a lot of stress. Cereset is a closed-loop acoustic stimulation intervention that has been studied in people with PTSD, insomnia, postural orthostatic tachycardia, and military veterans.
Who is the study for?
This trial is for adults over 18 who are the primary caregivers for patients with high-grade gliomas, such as astrocytoma or glioblastoma. Caregivers must be able to sit in a chair for 90 minutes and sign consent forms. They can't have used certain brain stimulation therapies recently, have severe hearing loss, weigh over 400 pounds, or be unable to abstain from alcohol or drugs during the study.Check my eligibility
What is being tested?
The Cereset intervention is being tested on caregivers of brain tumor patients to see if it helps manage stress. It's an acoustic therapy previously studied in PTSD and insomnia cases. Participants will undergo quality of life assessments and questionnaires alongside the Cereset sessions.See study design
What are the potential side effects?
Since this trial involves non-invasive acoustic stimulation therapy rather than medication, traditional side effects like those seen with drugs may not apply. However, participants might experience discomfort or other sensations related to sound exposure.
CERESET Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am caring for someone over 18 with a high-grade brain tumor.
CERESET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Completed Interventions
Secondary outcome measures
Caregiver Interview
Changes in Heart Rate - FAROS 180 device
Generalized Anxiety Disorder 7-item scale (GAD-7)
+3 moreCERESET Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention with Ambulatory TherapyExperimental Treatment4 Interventions
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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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,237 Total Patients Enrolled
Roy Strowd, MDPrincipal InvestigatorWake Forest University Health Sciences
6 Previous Clinical Trials
134 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My weight is at least 400 pounds.I do not binge drink, as defined by 4 drinks for women and 5 for men in one sitting.I am 18 years old or older.I can sit in a chair for 90 minutes without discomfort.I am caring for someone over 18 with a high-grade brain tumor.You have consumed a large amount of alcohol within the past month, such as drinking heavily on at least five separate days.You will not be able to stop using alcohol or recreational drugs during the study.I am the main person providing care for someone with glioma, without being paid.You drink a lot of alcohol, according to the Substance Abuse and Mental Health Services Administration.You can't have received certain types of brain stimulation or feedback therapies within a month before enrolling in the trial.I am on medication for an ongoing seizure disorder.I have used HIRREM or Cereset before.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention with Ambulatory Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities available to join this experiment?
"Indeed, the information available on clinicaltrials.gov clearly shows that this medical trial is still active and open for recruitment. The initial posting was made on February 1st 2023 with an update occurring later in November 17th 2022. This clinical study requires 24 individuals to be recruited from a single site."
Answered by AI
What is the upper limit of individuals participating in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this clinical trial is presently in its recruitment phase and has been since February 1st of 2023 as per the last update on November 17th 2022. A total of 24 patients need to be enrolled from a single medical facility."
Answered by AI
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