Neurofeedback to Aid Vets' Memory (TUNe)
Primary Purpose
Mild Cognitive Impairment
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring neurofeedback, amnestic MCI, wireless EEG, Bluegrass Memory Test, working memory
Eligibility Criteria
Inclusion Criteria:
- Veterans age 60 and older
Exclusion Criteria:
- Veterans diagnosed with PTSD, epilepsy schizophrenia, or use benzodiazapines
Sites / Locations
- Lexington VA Medical Center, Lexington, KY
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MCI patients
NC
Arm Description
Vets with mild cognitive impairment
Normal healthy Veterans
Outcomes
Primary Outcome Measures
EEG alpha band
alpha power under eyes closed and eyes open are linked to better mental state; likely biomarker for mild cognitive impairment.
Secondary Outcome Measures
memory-related potentials
Brainwaves that are linked to better memory performance
California Verbal Learning Test
A battery of neuropsychological testing cognitive functions
Full Information
NCT ID
NCT04446481
First Posted
June 3, 2020
Last Updated
April 18, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04446481
Brief Title
Neurofeedback to Aid Vets' Memory
Acronym
TUNe
Official Title
Tuning Up Memory-related Brain Potentials Using Real-time Neurofeedback in Older Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 5, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
neurofeedback, amnestic MCI, wireless EEG, Bluegrass Memory Test, working memory
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MCI patients
Arm Type
Experimental
Arm Description
Vets with mild cognitive impairment
Arm Title
NC
Arm Type
Active Comparator
Arm Description
Normal healthy Veterans
Intervention Type
Device
Intervention Name(s)
Neurofeedback
Other Intervention Name(s)
biofeedback
Intervention Description
Neurofeedback will be tested in both groups of Vets
Primary Outcome Measure Information:
Title
EEG alpha band
Description
alpha power under eyes closed and eyes open are linked to better mental state; likely biomarker for mild cognitive impairment.
Time Frame
6-8 weeks
Secondary Outcome Measure Information:
Title
memory-related potentials
Description
Brainwaves that are linked to better memory performance
Time Frame
6-8 weeks
Title
California Verbal Learning Test
Description
A battery of neuropsychological testing cognitive functions
Time Frame
About 6-8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Veterans age 60 and older
Exclusion Criteria:
Veterans diagnosed with PTSD, epilepsy schizophrenia, or use benzodiazapines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Jiang, PhD
Organizational Affiliation
Lexington VA Medical Center, Lexington, KY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lexington VA Medical Center, Lexington, KY
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502-2235
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Neurofeedback to Aid Vets' Memory
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