Sensory-Evoked Cortical Gamma Oscillation for Alzheimer's Disease
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one hour daily gamma frequency sensory stimulation from the investigational device for an 8 week period
Follow-up
Participants are monitored for safety and effectiveness after treatment, with neurophysiological testing repeated 4 weeks following the conclusion of therapy
What Are the Treatments Tested in This Trial?
Interventions
- GammaSense Stimulation device
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Tennessee Medical Center
Lead Sponsor