- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04446481
Neurofeedback to Aid Vets' Memory (TUNe)
Tuning Up Memory-related Brain Potentials Using Real-time Neurofeedback in Older Veterans
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
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Lexington, Kentucky, United States, 40502-2235
- Lexington VA Medical Center, Lexington, KY
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Veterans age 60 and older
Exclusion Criteria:
- Veterans diagnosed with PTSD, epilepsy schizophrenia, or use benzodiazepines
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MCI patients
Vets with mild cognitive impairment
|
Neurofeedback will be tested in both groups of Vets
Other Names:
|
|
Active Comparator: NC
Normal healthy Veterans
|
Neurofeedback will be tested in both groups of Vets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG alpha band
Time Frame: 6-8 weeks
|
alpha power under eyes closed and eyes open are linked to better mental state; likely biomarker for mild cognitive impairment.
|
6-8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
memory-related potentials
Time Frame: 6-8 weeks
|
Brainwaves that are linked to better memory performance
|
6-8 weeks
|
|
California Verbal Learning Test
Time Frame: About 6-8 weeks
|
A battery of neuropsychological testing cognitive functions
|
About 6-8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yang Jiang, PhD, Lexington VA Medical Center, Lexington, KY
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N3173-P
- RX-003173 (Other Grant/Funding Number: Department of Veterans Affairs)
- JIA-20-003-HE (Other Identifier: VA IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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