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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

Must not have

Anti-epileptic medication

Seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 12 weeks of treatment

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.

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.

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 below

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I live on my own without needing daily help.

Exclusion Criteria

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

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I am taking medication for epilepsy.

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I have a seizure disorder.

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I have been diagnosed with frontal temporal dementia.

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I have brain cancer.

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I have not had a stroke in the past 2 years.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 weeks of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Working Memory accuracy

Secondary study objectives

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

~1100

0 / 6Eligibility criteria met