Actively Recruiting

Phase Not Applicable
Age: 65Years - 89Years
All Genders
Healthy Volunteers
NCT03551392

Pilot Intervention With Near Infrared Stimulation

Led by University of Florida · Updated on 2025-01-27

24

Participants Needed

2

Research Sites

357 weeks

Total Duration

On this page

Sponsors

U

University of Florida

Lead Sponsor

M

McKnight Brain Research Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

The current study will test whether age-related cognitive and mood changes in older adults and those will be affected by near infrared (NIR) stimulation. The overall hypothesis, drawn from previous literature, is that exposure to NIR stimulation will have positive effects on brain health and will result in better cognitive and mood performance.

CONDITIONS

Official Title

Pilot Intervention With Near Infrared Stimulation

Who Can Participate

Age: 65Years - 89Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • No evidence of dementia or mild cognitive impairment based on cognitive screening tests within normal limits for age, education, and sex
  • Able to provide informed consent and perform cognitive and mood tests on a computer
  • At least 8th grade education or ability to read at an 8th grade level
  • Willingness to be randomized to receive real or sham intervention
  • Able to commit to 12 weeks of intervention plus time for pre- and post-testing
  • On stable doses of major medications for at least two months and plan to continue during study participation
  • Normal daily functional behavior
Not Eligible

You will not qualify if you...

  • History of major strokes or significant brain diseases affecting cognition, including brain surgery (except Parkinson's disease subgroup)
  • Unstable or uncontrolled medical conditions such as metabolic encephalopathy, HIV, moderate to severe kidney or liver disease
  • Current or past major psychiatric disorders including schizophrenia, active psychosis, bipolar disorder, major depressive episode, alcohol or substance abuse within the past six months
  • Use of antipsychotics, sedatives, or medications with significant anticholinergic effects
  • Use of photosensitive medications like steroids or retin-A within 15 days before intervention
  • Diagnosis of active cancer
  • Significant motor or visual impairments preventing computer use or color detection
  • Participation in cognitive training studies within the last 3 months or current involvement in other cognitive intervention studies
  • Inability to undergo brain imaging due to claustrophobia or presence of implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or ferromagnetic shrapnel

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of Arizona

Tucson, Arizona, United States, 85721

Actively Recruiting

2

University of Florida

Gainesville, Florida, United States, 32611

Actively Recruiting

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Research Team

D

Dawn Bowers, Ph.D.

CONTACT

A

Adam Woods, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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