Neurofeedback to Improve Working Memory in Mild Cognitive Impairment

NCT04566900 | Active Not Recruiting DMC

• 1 other identifier: 192022
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment

Keywords

neurofeedback

Outcome Measures

Primary Outcomes (1)

• Change in Working Memory accuracy

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

  From baseline to 12 weeks of treatment

Secondary Outcomes (3)

• Durability of Change in Working Memory accuracy

  From baseline to 4weeks post end of study

• Change in Gamma Band Response

  From baseline to 12 weeks of treatment

• Durability of Gamma Band Response

  From baseline to 4weeks post end of study

Study Arms (2)

Active Treatment

EXPERIMENTAL

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.

Behavioral: Neurofeedback

Placebo

SHAM COMPARATOR

Video and music progression will be random and will not depend on brain activity. Any progression will be by random chance alone.

Other: Placebo

Interventions

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.

Active Treatment

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.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California at San Diego

La Jolla, California, 92093, United States

Location

Related Publications (5)

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

  PMID: 23020641 BACKGROUND

• 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.

  PMID: 17915264 BACKGROUND

• 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.

  PMID: 1422803 BACKGROUND

• 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.

  PMID: 17015233 BACKGROUND

• 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.

  PMID: 12488788 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double-blind, randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: MCI subjects will be assigned to active intervention or placebo.

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 28, 2020
• Study Start: January 1, 2021
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)