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Behavioral Intervention
Neurofeedback for Mild Cognitive Impairment
N/A
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Living independently.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 12 weeks of treatment
Awards & highlights
Study Summary
This trial is studying a potential treatment for Alzheimer's disease that involves training people to change their brain function.
Who is the study for?
This trial is for individuals living independently with mild cognitive impairment (MCI), who can read English and consent to participate. It's not suitable for those with frontal temporal dementia, brain cancer, or recent stroke; people taking certain cognitive-affecting drugs like donepezil; or those with a history of significant head injury, seizures, or active substance abuse within the last year.Check my eligibility
What is being tested?
The study tests a computer-based neurofeedback program designed to improve working memory in MCI patients by enhancing brain activity. Participants will either receive this neurofeedback training or a placebo treatment to compare effectiveness in potentially slowing Alzheimer's progression.See study design
What are the potential side effects?
Neurofeedback is generally considered safe but may cause temporary discomfort like headache or fatigue. Since it involves focusing on tasks during sessions, some participants might experience mental strain or stress.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I live on my own without needing daily help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 12 weeks of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 12 weeks of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Working Memory accuracy
Secondary outcome measures
Change in Gamma Band Response
Durability of Change in Working Memory accuracy
Durability of Gamma Band Response
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TreatmentExperimental Treatment1 Intervention
Subjects will be given a choice of videos consisting of still images set to music. Whether the video progresses and music continues to play will depend on the subject's ability to maintain frontal gamma oscillatory activity within a prespecified range. Over successive weeks, the parameters for positive feedback (music and video progression) will become incrementally more difficult.
Group II: PlaceboPlacebo Group1 Intervention
Video and music progression will be random and will not depend on brain activity. Any progression will be by random chance alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neurofeedback
2019
Completed Phase 3
~1030
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,128 Previous Clinical Trials
1,552,291 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had problems with drugs or alcohol within the past year.I understand and agree to participate in this study voluntarily.I live on my own without needing daily help.I am taking medication for epilepsy.I am taking medications that may impact my thinking or memory.You have experienced a head injury in the past that caused you to lose consciousness.I have a seizure disorder.I have been diagnosed with frontal temporal dementia.I have brain cancer.I have not had a stroke in the past 2 years.You have mild problems with memory or thinking abilities.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Active Treatment
Awards:
This trial has 0 awards, including: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.
Are elderly people allowed to participate in this experiment?
"According to the guidelines set forth by this clinical trial, the minimum age requirement for patients is 50 and no older than 85 years old."
Answered by AI
Are there any more positions available for volunteers in this experiment?
"That is correct. The clinicaltrials.gov website indicates that the trial is still looking for patients. Originally, the trial was posted on 1/1/2021 and then last updated on 3/15/2022. They are hoping to find 112 patients from 1 site."
Answered by AI
If I meet the qualifications, may I join this clinical research project?
"112 patients that fit the age range of 50 to 85 and have experienced cognitive decline are eligible for this trial. The most important qualifying factor is that candidates must be able to live independently."
Answered by AI
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