Neurofeedback to Improve Working Memory in Mild Cognitive Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neurofeedback to Aid Vets' Memory

NCT04446481

Mild Cognitive Impairment

COMPLETED NA

Enhancing Frontal Lobes Plasticity in Mild Cognitive Impairment

NCT04583215

Mild Cognitive Impairment Memory Impairment

RECRUITING NA

Neurofeedback in Alzheimer's Disease

NCT03790774

Alzheimer Disease

TERMINATED NA

STRATEGIES to Improve Memory in Alzheimer's Disease

NCT04942184

Alzheimer Disease Dementia, Mild Mild Cognitive Impairment

WITHDRAWN NA

Improving Patient Memory for Treatment for Mild Cognitive Impairment

NCT05668481

Memory Impairment Sleep Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

MCI subjects will be assigned to active intervention or placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Double-blind, randomized.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Treatment

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 Type EXPERIMENTAL

Neurofeedback

Intervention Type 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

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

Group Type SHAM_COMPARATOR

Placebo

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neurofeedback

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.

Intervention Type BEHAVIORAL

Placebo

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 voluntary informed consent.

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 include medications as covariates as appropriate (e.g., presence v. absence; anticholinergic load).
9. The potential benefits of the study do not outweigh the potential risks of the study, as determined by the PI.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No