NCT04446481

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 5, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

3.7 years

First QC Date

June 3, 2020

Last Update Submit

October 14, 2025

Conditions

Mild Cognitive Impairment

Keywords

neurofeedbackamnestic MCIwireless EEGBluegrass Memory Testworking memory

Outcome Measures

Primary Outcomes (1)

  • EEG alpha band

    alpha power under eyes closed and eyes open are linked to better mental state; likely biomarker for mild cognitive impairment.

    6-8 weeks

Secondary Outcomes (2)

  • memory-related potentials

    6-8 weeks

  • California Verbal Learning Test

    About 6-8 weeks

Study Arms (2)

MCI patients

EXPERIMENTAL

Vets with mild cognitive impairment

Device: Neurofeedback

NC

ACTIVE COMPARATOR

Normal healthy Veterans

Device: Neurofeedback

Interventions

NeurofeedbackDEVICE

Neurofeedback will be tested in both groups of Vets

Also known as: biofeedback
MCI patientsNC

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans age 60 and older

You may not qualify if:

  • Veterans diagnosed with PTSD, epilepsy schizophrenia, or use benzodiazepines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lexington VA Medical Center, Lexington, KY

Lexington, Kentucky, 40502-2235, United States

Location

Related Publications (2)

  • 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.

    PMID: 35418848RESULT

  • 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.

    PMID: 39206795RESULT

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

NeurofeedbackBiofeedback, Psychology

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Yang Jiang, PhD

    Lexington VA Medical Center, Lexington, KY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Exp1. Protocol establishment: 15 cognitively intact and 15 Vets with mild cognitive impairment Exp2. Efficacy Testing: 20 Vets over the age of 60
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 25, 2020

Study Start

February 5, 2022

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

De-identified data will be analyzed and kept at least 6 years after project. Results will be shared via publications. The qualified researchers may contact PI and VA for further sharing of the research data.

Locations

US(1)