Neurofeedback to Aid Vets' Memory

NCT ID: NCT04446481

Last Updated: 2025-10-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-05

Study Completion Date

2025-09-30

Brief Summary

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

Military deployment is associated with increased risk of mild cognitive impairment (MCI). Combat stress related memory deficits has been well documented. Mild cognitive impairment such as memory deficits are the most common and earliest symptoms of Alzheimer's disease and related dementia (ADRD). The complaints about declined memory are common in healthy and cognitively intact civilian older adults, but less understood in aging Veterans. Brain training strategies to enhance cognitive skills and especially memory processes are unmet needs in aging Veterans who are at additional risk for MCI induced by ADRD. Since currently there is no effective drug treatment to stop cognitive decline, non-invasive brain training to boost memory functions in older Veterans is an increasingly attractive option to attenuating decline in memory.

Detailed Description

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

The proposed project is poised to investigate state-of-art neurofeedback (NF; biofeedback of brain activity) training for self-modulation of neural plasticity to boost memory performance in Veterans. The recent advance of NF with Brian-Computer Interface (BCI) has provided a novel way to examine brain functions and plasticity. Thus far, there have been limited applications that have developed effective experimental and clinical paradigms for rehabilitation in Veterans. Historically, brainwave patterns during memory task performance have been analysed offline, a methodology which does not allow real-time NF modulation and training. The central hypothesis guiding this research is that optimal memory-related brainwave patterns of a Veteran can be trained. The online NF allows maximization of brainwave patterns associated with healthier memory states.

The development of efficient NF paradigms to augment memory performance is an important first step for the application of this nonpharmacologic intervention to improve combat Veterans' memory functions and potential for treating MCI due to mild TBI or pain. The pilot work will start with wider range of Veterans using state-of-the-art wearable wireless brain-computer interface headset, which is affordable and can be easily set up in VAMCs and eventually in remote assessment settings. This innovative, cognitive neuroscience based, nonpharmacologic intervention serves to revolutionize the diagnosis and treatment of combat Veterans who are at risk for degenerative dementia.

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

NON_RANDOMIZED

Intervention Model

PARALLEL

Exp1. Protocol establishment: 15 cognitively intact and 15 Vets with mild cognitive impairment

Exp2. Efficacy Testing: 20 Vets over the age of 60
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

MCI patients

Vets with mild cognitive impairment

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type DEVICE

Neurofeedback will be tested in both groups of Vets

NC

Normal healthy Veterans

Group Type ACTIVE_COMPARATOR

Neurofeedback

Intervention Type DEVICE

Neurofeedback will be tested in both groups of Vets

Interventions

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

Neurofeedback

Neurofeedback will be tested in both groups of Vets

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

biofeedback

Eligibility Criteria

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

Inclusion Criteria

* Veterans age 60 and older

Exclusion Criteria

* Veterans diagnosed with PTSD, epilepsy schizophrenia, or use benzodiazepines
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yang Jiang, PhD

Role: PRINCIPAL_INVESTIGATOR

Lexington VA Medical Center, Lexington, KY

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lexington VA Medical Center, Lexington, KY

Lexington, Kentucky, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Jiang Y, Jessee W, Hoyng S, Borhani S, Liu Z, Zhao X, Price LK, High W, Suhl J, Cerel-Suhl S. Sharpening Working Memory With Real-Time Electrophysiological Brain Signals: Which Neurofeedback Paradigms Work? Front Aging Neurosci. 2022 Mar 28;14:780817. doi: 10.3389/fnagi.2022.780817. eCollection 2022.

Reference Type RESULT
PMID: 35418848 (View on PubMed)

Jiang Y, Neal J, Sompol P, Yener G, Arakaki X, Norris CM, Farina FR, Ibanez A, Lopez S, Al-Ezzi A, Kavcic V, Guntekin B, Babiloni C, Hajos M. Parallel electrophysiological abnormalities due to COVID-19 infection and to Alzheimer's disease and related dementia. Alzheimers Dement. 2024 Oct;20(10):7296-7319. doi: 10.1002/alz.14089. Epub 2024 Aug 29.

Reference Type RESULT
PMID: 39206795 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2022.780817/full

Sharpening Working Memory With Real-Time Electrophysiological Brain Signals: Which Neurofeedback Paradigms Work?

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RX-003173

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

JIA-20-003-HE

Identifier Type: OTHER

Identifier Source: secondary_id

N3173-P

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mild TBI Assessment & Rehabilitation
NCT02920788 ACTIVE_NOT_RECRUITING NA