Clinical trial NCT04446481: Neurofeedback to Aid Vets' Memory
Official title: Tuning Up Memory-related Brain Potentials Using Real-time Neurofeedback in Older Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: neurofeedback
amnestic MCI
wireless EEG
Bluegrass Memory Test
working memory
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-06-25
Enrollment: 4
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Exp1. Protocol establishment: 15 cognitively intact and 15 Vets with mild cognitive impairment

Exp2. Efficacy Testing: 20 Vets over the age of 60
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Veterans age 60 and older

Exclusion Criteria:

* Veterans diagnosed with PTSD, epilepsy schizophrenia, or use benzodiazapines

Primary outcomes:
measure: EEG alpha band
timeFrame: 6-8 weeks
Secondary outcomes:
measure: memory-related potentials
timeFrame: 6-8 weeks
measure: California Verbal Learning Test
timeFrame: About 6-8 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Lexington VA Medical Center, Lexington, KY
state: Kentucky
Study officials:
affiliation: Lexington VA Medical Center, Lexington, KY
name: Yang Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.