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Behavioural Intervention

Sensory-Evoked Cortical Gamma Oscillation for Alzheimer's Disease

N/A

Recruiting

Led By Roberto Fernandez-Romero, MD

Research Sponsored by University of Tennessee Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals ages 60 and older with established diagnosis of Alzheimer's Disease as defined by the current consensus criteria for AD (Albert et al, 2011, Jack et al, 2011; McKhann et al, 2011)

Able to consent for themselves based upon the MacArthur Competence Assessment Tool for Clinical Research

Must not have

Claustrophobic to the point that medication is required

Severe dementia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trialtests if a device that stimulates the brain with light and sound can help treat Alzheimer's patients.

Who is the study for?

This trial is for English-speaking individuals aged 60 or older with a confirmed diagnosis of Alzheimer's Disease. Participants must be able to consent for themselves and may need to undergo a Lumbar Puncture if they haven't been tested for specific AD markers. It excludes those with severe dementia, incompatible implants like pacemakers, other cognitive impairments, or claustrophobia requiring medication.

What is being tested?

The study tests the GammaSense Stimulation device that uses visual and auditory stimulation to evoke gamma oscillation in the brain. The goal is to improve sensory processing and cognitive function in Alzheimer's patients, measured by EEG and ERP.

What are the potential side effects?

Potential side effects are not explicitly mentioned but could include discomfort from wearing the device, fatigue from sensory stimulation, headache or dizziness post-stimulation, or skin irritation at electrode sites.

Eligibility Criteria

Inclusion Criteria

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

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I am 60 or older and have been diagnosed with Alzheimer's Disease.

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I understand the details of this clinical trial and can make decisions about my care.

Exclusion Criteria

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

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I need medication to manage my claustrophobia.

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I have severe memory loss that affects my daily life.

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I am unable to make medical decisions for myself due to cognitive impairment.

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I do not have any conditions that majorly affect my thinking or memory.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cognitive Status

Cortical Network Functioning

Secondary study objectives

Resting state functional magnetic resonance imaging

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: AD PatientsExperimental Treatment1 Intervention

Patients with Alzheimer's Disease, as verified by positive A(beta)-PET and/or CSF tau/A(beta) biomarkers, who will receive one hour daily gamma frequency sensory stimulation from the investigational device for an 8 week period.

0 / 6Eligibility criteria met