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Mild Cognitive ImpairmentNCT04566900

Neurofeedback to Improve Working Memory in Mild Cognitive Impairment

A study testing Neurofeedback in people with Mild Cognitive Impairment, run by University of California, San Diego at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Neurofeedback
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
1 siteUnited States
Study dates
1 Jan 2021to 31 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California at San Diego

    La Jolla, California, 92093

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
Neurofeedback, Placebo
Keywords
neurofeedback
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeurofeedbackBehavioural

    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.

  • PlaceboOther

    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.

Study groups in NCT04566900
Study groupRoleWhat they receive
Active TreatmentExperimentalSubjects 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.
Receives: Behavioral: Neurofeedback
PlaceboSham comparatorVideo and music progression will be random and will not depend on brain activity. Any progression will be by random chance alone.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Working Memory accuracy

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

    Measured: From baseline to 12 weeks of treatment

Secondary outcomes (3)

  1. Durability of Change in Working Memory accuracy

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

    Measured: From baseline to 4weeks post end of study

  2. Change in Gamma Band Response

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

    Measured: From baseline to 12 weeks of treatment

  3. Durability of Gamma Band Response

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

    Measured: From baseline to 4weeks post end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2020
  2. Study start1 Jan 2021
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
MCI subjects will be assigned to active intervention or placebo.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04566900
Sponsor's protocol ID
192022
Status last verified
May 2026
First submitted
17 Sep 2020
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.

    PubMed 23020641

  • Dohnel K, Sommer M, Ibach B, Rothmayr C, Meinhardt J, Hajak G. Neural correlates of emotional working memory in patients with mild cognitive impairment. Neuropsychologia. 2008 Jan 15;46(1):37-48. doi: 10.1016/j.neuropsychologia.2007.08.012. Epub 2007 Aug 23.

    PubMed 17915264

  • Leuchter AF, Newton TF, Cook IA, Walter DO, Rosenberg-Thompson S, Lachenbruch PA. Changes in brain functional connectivity in Alzheimer-type and multi-infarct dementia. Brain. 1992 Oct;115 ( Pt 5):1543-61. doi: 10.1093/brain/115.5.1543.

    PubMed 1422803

  • Uhlhaas PJ, Singer W. Neural synchrony in brain disorders: relevance for cognitive dysfunctions and pathophysiology. Neuron. 2006 Oct 5;52(1):155-68. doi: 10.1016/j.neuron.2006.09.020.

    PubMed 17015233

  • Stam CJ, van Cappellen van Walsum AM, Pijnenburg YA, Berendse HW, de Munck JC, Scheltens P, van Dijk BW. Generalized synchronization of MEG recordings in Alzheimer's Disease: evidence for involvement of the gamma band. J Clin Neurophysiol. 2002 Dec;19(6):562-74. doi: 10.1097/00004691-200212000-00010.

    PubMed 12488788

Questions about this trial

What is this clinical trial studying?

A study testing Neurofeedback in people with Mild Cognitive Impairment, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Working Memory accuracy (time frame: From baseline to 12 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04566900, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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