NCT06217575

Brief Summary

Older veterans with a history of mild brain trauma exhibit early cognitive challenges, especially in driving-related tasks. This is attributed to alterations in the brain's excitatory/inhibitory (E/I) balance. This pilot project investigates this phenomenon by leveraging electroencephalography (EEG) to measure parietal lobe alpha rhythms during visual attention tasks. The hypothesis is that targeted visual attention training can modulate these alpha rhythms, improving instrumental activities in daily life. However, outcomes from such training vary, possibly due to individual differences in cortical inhibitory functions. This study will assess the relationship between EEG measures of E/I balance pre- and post-visual attention training and its effects on processing speeds in aging veterans. Our findings aim to provide a foundation for customized therapies and interventions for veterans with and without a history of brain trauma.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Jul 2025Apr 2028

First Submitted

Initial submission to the registry

December 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

August 29, 2025

Status Verified

May 1, 2025

Enrollment Period

2.6 years

First QC Date

December 14, 2023

Last Update Submit

August 21, 2025

Conditions

Keywords

cognitive declinevisual attention traininguseful field of viewmild traumatic brain injuryaging

Outcome Measures

Primary Outcomes (1)

  • Specific domains of cognitive function

    Measured through composite scores: Executive function/mental flexibility will be measured with the Trail Making Tests, Part A and Part B. The results for both TMT-A and TMT-B are reported as the number of seconds required to complete a task. Processing speed (using the Digit Symbol Substitution Test) will be measured as the total correct number-symbol matches achieved in 90 seconds. Verbal fluency (semantic, animal naming, and phonemic) will be measured by using the Controlled Oral Word Association Test and assessed through the total number of words identified by category and letter.

    6 weeks

Secondary Outcomes (2)

  • General Cognitive function

    6 weeks

  • Quality of life as measured by SF-12

    6 Weeks

Study Arms (2)

Visual Attention Training

ACTIVE COMPARATOR

Visual attention training is at the core of well-known training programs such as useful field of view (UFOV) training. The adapted nature of the computerized training approach affords individual differences in performance at the training outset while evaluating gains using specified performance criteria. Training parameters (duration of stimulus presentation for processing speed) are adjusted based on accuracy.

Behavioral: Visual Attention Training

Alpha Neurofeedback training

EXPERIMENTAL

Electroencephalogram (EEG) based neurofeedback (NFB) is a method in which brain activity is modulated via self-induced increases or decreases in the power of selected EEG frequency bands. The subject's control over his or her EEG activity is mediated with visual feedback. We will employ alpha neurofeedback training to examine how this conditioning paradigm may improve visual attention.

Behavioral: Alpha neurofeedback training

Interventions

Alpha neurofeedback training affords the participant the ability to monitor cortical EEG waves and entrain to a specific rhythm using visual feedback. Alpha is measured between 8-12Hz and is associated with cortical inhibition. Aging related changes in alpha have been associated with loss of modulation ability. However, alpha training may afford increased perception of visual details.

Also known as: alpha modulation, neurofeedback, eeg-nfb
Alpha Neurofeedback training

Visual attention training involves repeated testing on the location and identity of objects in the visual field. Also called the "Dual Decision" task training, objects are briefly presented in a radial field of view surrounding a gaze fixation point. The participant is asked to remember the location and object presented within the field. The test progressively increases in difficulty by limiting the amount of time the object is presented on screen. Accuracy is measured by either a correct or incorrect response (binary response).

Also known as: Standard Visual Attention Training, dual decision
Visual Attention Training

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages: 18-35 (Younger Group); Ages 50-80 (Healthy Older Group); Ages 50-85 (persons with a history of mild traumatic brain injury)
  • English speaking
  • Veterans with mild traumatic brain injury (mTBI):
  • A history of mTBI confirmed by the Ohio State University TBI Identification Method-Short Form (including a requirement that the mTBI caused a loss of consciousness lasting less than 30 min).
  • An additional note will be made for Veterans with mTBI with a report of objective or subjective cognitive decline not meeting the criteria (i.e.- Montreal Cognitive Assessment (MoCA) \>23) for impairment

You may not qualify if:

  • Failure to provide informed consent
  • Metal of foreign objects in the body that would interfere with an magnetic resonance imaging (MRI) or transcranial magnetic stimulations (TMS)
  • History of penetrating head wounds or a diagnosis of moderate/severe TBI
  • Participants with significant visual field deficits were excluded, as were those with active suicidal ideation
  • Suicidal ideation will be assessed with the Columbia suicidality scale (C-SSRS)
  • Participants with active ideation will be referred to the Veteran Crisis Line (988) (or walked) to the Front Door program at the Birmingham East clinic
  • Participation in a concurrent clinical trial that could affect study outcome (however, participation in standard treatments e.g. occupational therapy or use of prescribed medications such as antidepressants is acceptable)
  • Smoker \> 1 pack per day
  • Significant cognitive impairment defined as \<23 on Montreal Cognitive Assessment (MoCA) or diagnosis of mild cognitive impairment or dementia
  • Visual (corrected acuity \<20/80) and motor capacity (completion of 9-hole pegboard) to use a computerized intervention
  • In-patient status
  • Severe visual impairment, which would preclude completion of the assessments
  • Progressive, degenerative neurologic disease, e.g., Parkinsons Disease, multiple sclerosis
  • Severe rheumatologic or orthopedic diseases, e.g., awaiting joint replacement Actively taking GABAergic agonist/antagonist medication (benzodiazepines, gabapentin, etc.)
  • Terminal illness with a life expectancy of less than 12 months, as determined by a physician
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH19 933 19th St S

Birmingham, Alabama, 35223, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain ConcussionCognitive Dysfunction

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesHead Injuries, ClosedWounds, NonpenetratingCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Central Study Contacts

Keith M McGregor, PhD

CONTACT

Ashton Weber, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Behavioral intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 14, 2023

First Posted

January 22, 2024

Study Start

July 1, 2025

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

August 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations