Neurofeedback to Aid Vets' Memory

Mild Cognitive Impairment Clinical Trial

— TUNe  

Official title:

Tuning Up Memory-related Brain Potentials Using Real-time Neurofeedback in Older Veterans

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04446481
• Other study ID #: N3173-P
• Secondary ID: RX-003173JIA-20-
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 5, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Veterans age 60 and older

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Neurofeedback
Neurofeedback will be tested in both groups of Vets

Locations

Country	Name	City	State
United States	Lexington VA Medical Center, Lexington, KY	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	memory-related potentials	Brainwaves that are linked to better memory performance	6-8 weeks
Secondary	California Verbal Learning Test	A battery of neuropsychological testing cognitive functions	About 6-8 weeks