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NCT Number: NCT04566900

Neurofeedback to Improve Working Memory in Mild Cognitive Impairment

Mild cognitive impairment (MCI) has been identified as an early phase of Alzheimer's disease (AD), a neurodegenerative disorder expected to affect 13.9 million Americans by 2060. AD causes a progressive cognitive decline, including problems related to learning and memory, that adversely affects life quality. Treatment intervention at the MCI stage of the disease could potentially slow down the rate at which people may convert from MCI to AD. Increasing evidence suggests that abnormal activity in frontal regions of the brain is associated with cognitive deficits observed in AD. Furthermore, previous research has shown that neurofeedback (NFB) training targeting these regions can improve memory, making it a potential treatment for AD. NFB is a technique where an individual learns to change his/her brain function in a particular direction, once that function has been made accessible through a visual or auditory metaphor. We are proposing a novel, computer-based brain-training program to enhance frontal gamma oscillatory activity in individuals with MCI. Results from this study will build the scientific foundation necessary for larger clinical trials dedicated to improving treatment options and outcomes for patients with MCI.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California at San Diego

La Jolla, California, 92093, United States

About this study

This is a randomized, double-blind, clinical trial to test the efficacy of gamma-neurofeedback (G-NFB) compared to a placebo (P-NFB) in individuals with MCI. 112 consented participants will be randomized to receive G-NFB (n=56) or placebo-NFB (n=56) during 30-45 minute sessions twice per week for 12 weeks (24 total sessions). Memory and other cognitive domains will be measured using paper and pencil and computerized tests every 4 weeks during the study and at 4 weeks post completion of study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet criteria for mild cognitive impairment (MCI).
  • Living independently.
  • Literate in English.
  • Competent to participate in the informed consent process and provide voluntary informed consent.

Exclusion criteria

  • Frontal temporal dementia
  • Active alcohol or substance use disorder within the past year.
  • Brain cancer
  • Stroke within the last 2 years
  • Anti-epileptic medication
  • Prior head injury involving loss of consciousness
  • Seizure disorder
  • Use of medications likely to affect cognitive function (cf. donepezil, memantine). We will not exclude for other medications but will examine their effects and include medications as covariates as appropriate (e.g., presence v. absence; anticholinergic load).
  • The potential benefits of the study do not outweigh the potential risks of the study, as determined by the PI.

Treatment and study plan

Neurofeedback

Behavioral

Neurofeedback is a technique where brain functions are made accessible to the subject in the form of a metaphor. For instance, frontal brain activity may be shown as an airplane flying. Once the activity is made accessible, the subject can modulate it in a pre-specified direction. The parameters used to achieve successful feedback are made difficult over time and hence the brain is taught or conditioned to improve performance.

Placebo

Other

Subjects in this arm will undergo all of the same testing as active treatment. Music and video progression will not depend on brain activity. Instead feedback will be random.

Primary outcomes

  1. Change in Working Memory accuracy

    Time frame: From baseline to 12 weeks of treatment

    Change in the computerized test, N-back will be used to measure working memory.

Secondary outcomes

  1. Durability of Change in Working Memory accuracy

    Time frame: From baseline to 4weeks post end of study

    Change in the computerized test, N-back will be used to measure working memory.

  2. Change in Gamma Band Response

    Time frame: From baseline to 12 weeks of treatment

    Change in Gamma oscillations will be measured while the subject performs the n-back task.

  3. Durability of Gamma Band Response

    Time frame: From baseline to 4weeks post end of study

    Change in Gamma oscillations will be measured while the subject performs the n-back task.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Enhancing Gamma Band Response in Mild Cognitive Impairment to Improve Working Memory

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2020
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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