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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 60 or older and have been diagnosed with Alzheimer's Disease.
Select...
I understand the details of this clinical trial and can make decisions about my care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cognitive Status
Cortical Network Functioning
Secondary outcome measures
Resting state functional magnetic resonance imaging
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.
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Who is running the clinical trial?
University of Tennessee Medical CenterLead Sponsor
5 Previous Clinical Trials
267 Total Patients Enrolled
Roberto Fernandez-Romero, MDPrincipal InvestigatorUniversity of Tennessee Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need medication to manage my claustrophobia.I have severe memory loss that affects my daily life.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.You have a pacemaker or other implants that may not work with MRI scans.I am unable to make medical decisions for myself due to cognitive impairment.I have positive brain markers for Alzheimer's or am willing to undergo a spinal tap test.I do not have any conditions that majorly affect my thinking or memory.
Research Study Groups:
This trial has the following groups:- Group 1: AD Patients
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.
How many participants are engaged in this experiment?
"Precisely, the information found on clinicaltrials.gov suggests that this medical study is still actively recruiting patients. This trial was first shared on July 1st 2022 and recently modified on October 31st 2022. It requires 20 individuals to be registered from a single site."
Answered by AI
Are there any vacancies available for participation in this research?
"Indeed, information displayed on clinicaltrials.gov confirms that this medical experiment is presently seeking participants and has been since July 1st 2022. The study requires 20 patients to be recruited from a single location and was last updated on October 31st 2022."
Answered by AI
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