Neurofeedback to Improve Working Memory in Mild Cognitive Impairment

Last updated: October 23, 2024
Sponsor: University of California, San Diego
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mild Cognitive Impairment

Dementia

Memory Loss

Treatment

Neurofeedback

Placebo

Clinical Study ID

NCT04566900
192022
  • Ages 50-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Meet criteria for mild cognitive impairment (MCI).

  2. Living independently.

  3. Literate in English.

  4. Competent to participate in the informed consent process and provide voluntaryinformed consent.

Exclusion

Exclusion Criteria:

  1. Frontal temporal dementia

  2. Active alcohol or substance use disorder within the past year.

  3. Brain cancer

  4. Stroke within the last 2 years

  5. Anti-epileptic medication

  6. Prior head injury involving loss of consciousness

  7. Seizure disorder

  8. Use of medications likely to affect cognitive function (cf. donepezil, memantine).We will not exclude for other medications but will examine their effects and includemedications as covariates as appropriate (e.g., presence v. absence; anticholinergicload).

  9. The potential benefits of the study do not outweigh the potential risks of thestudy, as determined by the PI.

Study Design

Total Participants: 112
Treatment Group(s): 2
Primary Treatment: Neurofeedback
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • University of California at San Diego

    La Jolla, California 92093
    United States

    Active - Recruiting

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