What side effects are associated with this type of intervention?

Common treatments for brain tumors include surgery, radiation therapy, and chemotherapy. Surgery can lead to complications such as infection, bleeding, and neurological deficits. Radiation therapy often causes fatigue, hair loss, skin changes, and potential long-term cognitive effects. Chemotherapy side effects include nausea, vomiting, hair loss, and increased risk of infection. For treatments similar to Cereset, which involves closed-loop acoustic stimulation, there is limited specific data, but general side effects of non-invasive neuromodulation techniques can include headache, scalp discomfort, and transient dizziness.

What prior FDA approvals exist?

FDA-approved treatments for brain tumors primarily include various forms of chemotherapy, radiation therapy, and targeted therapies. For instance, temozolomide is a commonly used chemotherapeutic agent for glioblastoma, often in combination with radiation therapy. Bevacizumab, an anti-angiogenic drug, is approved for recurrent glioblastoma. Additionally, tumor-treating fields (TTF) therapy, such as the NovoTTF-100A system, is an FDA-approved modality that uses electric fields to disrupt cancer cell division. While these treatments differ from the closed-loop acoustic stimulation studied in the Cereset trial, they represent the current standard of care for brain tumors.

What other types of research exist?

Promising alternatives to Cereset for brain tumor patients include Peripheral Focused Ultrasound Stimulation (pFUS), which offers precision neuromodulation, and S-MRUT (Sectored-Multiring Ultrasonic Transducer) for selective powering of brain implants. Additionally, systemic treatments like mTORC1 inhibitors and combined therapies such as bevacizumab and everolimus show potential for managing brain tumors.

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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

Must not have

Trial participant's weight is greater than or equal to 400 pounds at time of enrollment (chair limit).

Trial participant has a known seizure disorder requiring ongoing anti-epileptics prescribed specifically for seizure disorder.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if Cereset, a sound-based treatment, can help stressed caregivers of high-grade glioma patients by using real-time sound feedback to balance brain activity.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am caring for someone over 18 with a high-grade brain tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My weight is at least 400 pounds.

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I am on medication for an ongoing seizure disorder.

Select...

I have used HIRREM or Cereset before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Completed Interventions

Secondary study objectives

Caregiver Interview

Changes in Heart Rate - FAROS 180 device

Generalized Anxiety Disorder 7-item scale (GAD-7)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for brain tumors include radiation therapy, chemotherapy, surgical resection, and innovative approaches like closed-loop acoustic stimulation (Cereset). Radiation therapy works by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate. Chemotherapy uses drugs to target and kill rapidly dividing cells, including cancer cells. Surgical resection involves physically removing the tumor from the brain. Closed-loop acoustic stimulation, such as Cereset, aims to reduce stress and improve brain function by using sound waves to influence brain activity. These treatments are crucial for brain tumor patients as they offer multiple avenues to control tumor growth, alleviate symptoms, and improve quality of life.

Piezoelectric barium titanate nanostimulators for the treatment of glioblastoma multiforme.Convection enhanced drug delivery of novel therapeutic agents to malignant brain tumors.Low-grade gliomas: clinical and pathobiological aspects.