20 Participants Needed

Sensory-Evoked Cortical Gamma Oscillation for Alzheimer's Disease

KD
RF
Overseen ByRoberto Fernandez-Romero, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Tennessee Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach for Alzheimer's Disease using a device called GammaSense. The device provides sensory stimulation to produce brain waves (gamma oscillation) that may aid memory and thinking skills. Participants will use the device daily for eight weeks. It suits individuals 60 and older who have Alzheimer's and can communicate in English. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance memory and thinking skills.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the GammaSense Stimulation device is safe for Alzheimer's Disease patients?

Research has shown that the GammaSense Stimulation device is generally safe for people. An early study found that patients handled the one-hour daily therapy well and suggested that the device might help improve brain function. Another study tested daily 40 Hz stimulation in five Alzheimer's patients and found that the treatment was well-tolerated over time. The GammaSense device uses non-invasive sensory stimulation, meaning it doesn't require surgery or medication. This method aims to support brain health without causing harm. Overall, the evidence so far indicates that the treatment is safe for people with Alzheimer's.12345

Why are researchers excited about this trial?

The GammaSense Stimulation device is unique because it uses gamma frequency sensory stimulation, a novel approach for treating Alzheimer's disease. Unlike current treatments that primarily focus on managing symptoms, this method aims to target the brain's electrical activity to potentially alter disease progression. Researchers are excited about this treatment as it introduces a non-invasive way to engage with the brain's natural rhythms, possibly offering a new avenue for therapy that could complement or enhance existing options.

What evidence suggests that the GammaSense Stimulation device is effective for Alzheimer's Disease?

Research has shown that stimulating certain brain waves, called gamma oscillations, at 40 Hz using sensory devices can aid in Alzheimer's Disease. Studies in animals and humans suggest that this 40 Hz stimulation might reduce harmful proteins linked to Alzheimer's, such as amyloid and tau. In a small study, five patients with mild Alzheimer's safely used this stimulation daily for two years and experienced positive effects. In this trial, participants with Alzheimer's Disease will receive daily gamma frequency sensory stimulation using the GammaSense Stimulation device for an 8-week period. GammaSense Stimulation aims to use these findings as a new way to support brain function and slow the progression of Alzheimer's.12467

Who Is on the Research Team?

RF

Roberto Fernandez-Romero, MD

Principal Investigator

University of Tennessee Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I understand the details of this clinical trial and can make decisions about my care.
I am 60 or older and have been diagnosed with Alzheimer's Disease.
Fluent and literate in English language
See 1 more

Exclusion Criteria

I need medication to manage my claustrophobia.
I have severe memory loss that affects my daily life.
You have a pacemaker or other implants that may not work with MRI scans.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one hour daily gamma frequency sensory stimulation from the investigational device for an 8 week period

8 weeks
Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with neurophysiological testing repeated 4 weeks following the conclusion of therapy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GammaSense Stimulation device
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: AD PatientsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Tennessee Medical Center

Lead Sponsor

Trials
7
Recruited
450+

Published Research Related to This Trial

A 6-month study involving 22 patients with mild to moderate Alzheimer's disease showed that daily 40 Hz gamma sensory stimulation therapy was well tolerated and helped maintain functional abilities, unlike the sham group which experienced a decline.
Patients receiving the active treatment had improved sleep quality, as indicated by reduced nighttime activity, suggesting that gamma sensory stimulation may have beneficial effects on both sleep and cognitive function in Alzheimer's patients.
Sensory-Evoked 40-Hz Gamma Oscillation Improves Sleep and Daily Living Activities in Alzheimer's Disease Patients.Cimenser, A., Hempel, E., Travers, T., et al.[2021]
In a study involving 15 participants and one epilepsy patient, incorporating cognitive tasks during Gamma ENtrainment Using Sensory stimulation (GENUS) sessions enhanced the strength and reach of gamma brainwave responses, particularly affecting deep brain areas like the hippocampus.
This suggests that adding cognitive workload to GENUS therapy could improve its effectiveness for Alzheimer's disease treatment by better engaging critical brain regions associated with memory and cognition.
Cognitive tasks propagate the neural entrainment in response to a visual 40 Hz stimulation in humans.Khachatryan, E., Wittevrongel, B., Reinartz, M., et al.[2022]
Daily exposure to 40 Hz synchronized sound and light stimuli for 2 weeks significantly improved hippocampal long-term potentiation (LTP) in three rat models of early Alzheimer's disease, suggesting a potential therapeutic effect.
The improvement in LTP was linked to a reduction in pro-inflammatory mechanisms, as indicated by a negative correlation with active caspase-1 levels, highlighting the importance of inflammation in the treatment strategy.
Gamma-patterned sensory stimulation reverses synaptic plasticity deficits in rat models of early Alzheimer's disease.Yang, Y., Ondrejcak, T., Hu, NW., et al.[2023]

Citations

An update on the use of gamma (multi)sensory stimulation for ...Several animal studies show that inducing gamma oscillations through (multi)sensory stimulation at 40 Hz has the potential to impact AD-related cognitive ...
Gamma sensory stimulation in mild Alzheimer's dementia: An ...Five mild Alzheimer's disease (AD) patients safely used daily 40 Hz audiovisual stimulation for 2 years. Late-onset AD (LOAD) patients showed ...
Visual gamma stimulation induces 40 Hz neural ...Nonpharmaceutical approaches based on gamma entrainment using sensory stimuli (GENUS) have shown promise in reducing Alzheimer's disease ...
Gamma frequency sensory stimulation in mild probable ...Non-invasive Gamma ENtrainment Using Sensory stimulation (GENUS) at 40Hz reduces Alzheimer's disease (AD) pathology such as amyloid and tau levels, prevents ...
40 Hz multisensory stimulation therapy for cognitive impairmentThis study explores the impact of a 40 Hz multisensory stimulation treatment on brain function, behavior, and disease progression in animal models
009/2022 - GAMMASENSE FOR ALZHEIMER'S DISEASEThe early study showed that one-hour therapy with GammaSense, a gamma sensory simulation device was well-tolerated and has the potential to improve functional ...
Review: Evidence expanding that 40Hz gamma stimulation ...“Our ultimate goal, therefore, is to translate GENUS discoveries into a safe, accessible, and non-invasive therapy for AD patients.” The MIT ...
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