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AgingNCT03551392

Pilot Intervention With Near Infrared Stimulation

A study testing Medx Console System and Vielight 810 intranasal stand alone unit in people with Aging, run by University of Florida at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 65 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Medx Console System and Vielight 810 intranasal stand alone unit
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesUnited States
Study dates
26 Jun 2019to 30 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • No evidence of dementia or Mild Cognitive Impairment based on cognitive screening (i.e., Montreal Cognitive Assessment (MoCA) scores within normal limits for age , education, and sex using the NACC Uniform Data Set (UDS) norms or Dementia Rating Scale (DRS-2) scores <5thile), and age-appropriate delayed Story recall (i.e., WMS-III Logical Memory) and confrontation naming (Boston Naming Test)
  • Able to provide informed consent and perform cognitive and mood measures on a computer
  • At least 8th grade education and/or ability to read at 8th grade level
  • Willingness to be randomized to Sham or Real intervention
  • Can devote 12 weeks to the intervention, and additional time for pre and post testing
  • On stable doses of major medications; Since some older adults with subjective memory complaints may be prescribed acetylcholinererase inhibitors or related medications by their primary care physicians (i.e., donepezil, rivastigmine, galantaominhe, memantime, or other potential memory-enhancing agent(s), we will not exclude them as long as they have been on stable medications for at least two months and plan to continue this medication during study participation.
  • Normal functional behavior in terms of daily activities

Who cannot join

  • Previous major strokes or other known significant brain abnormalities or diseases affecting cognition (i.e., multiple sclerosis, seizure disorder, brain surgery, moderate TBI, etc.). No history of brain surgery. Exceptions are a diagnosis of Parkinson's disease for the PD subgroup.
  • Unstable and uncontrolled medical conditions (metabolic encephalopathy, HIV, moderate to severe kidney or liver disease)
  • Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months. The study team is not excluding individuals who are taking antidepressants or anti-anxiety medications, however, use of antidepressants and anxiolytics will be recorded and data will be analyzed in post-hoc analyses
  • Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
  • Use of photo-sensitive medications such as steroids or retin-A within 15 days of the study intervention
  • Diagnosis of active cancer
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  • Significant motor or visual disturbance that would prevent one from using a computer or detecting colors
  • Previous participation in a cognitive training study within the last 3 months or current involvement in another study involving cognitive training or intervention at the time of participation
  • Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Florida

    Gainesville, Florida, 32611

  • University of Arizona

    Tucson, Arizona, 85721

Other trials in United States

About this study

Official title: Pilot Intervention With Near Infrared Stimulation: Revitalizing Cognition in Older Adults

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.

Read the detailed description

This is a multi-site pilot study of the efficacy of NIR stimulation for enhancing cognition and mood in nondemented older adults. Sites include the University of Florida and University of Arizona. Prior research suggests that NIR exposure may be neuroprotective and increases energy available to neurons. The current study will test whether age-related cognitive and mood changes in older adults will be affected by near infrared (NIR) stimulation.

The study team will randomize older adults into treatment groups and evaluate neuroimaging and cognitive outcome measures, before and after a 12-week intervention involving transcranial and intranasal NIR. The protocol will involve both " lab" and " home-based" 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
Aging
Being tested
Medx Console System, Sham Medx Console System, Vielight 810 intranasal stand alone unit, Sham Vielight 810 intranasal stand alone unit
Keywords
Cognitive Aging, Photobiomodulation, Low Level Light Therapy, Near Infrared (NIR) Light, Neuromodulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medx Console SystemDevice

    Also called Low Level Light Therapy, Photobiomodulation, Transcranial Near Infrared Stimulation

    This intervention delivers near infrared (NIR) light using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks.

  • Sham Medx Console SystemDevice

    This intervention uses sham application of near infrared light (NIR) using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks.

  • Vielight 810 intranasal stand alone unitDevice

    Daily at home intranasal NIR stimulation sessions, 25 minutes in duration, 4 days each week.

  • Sham Vielight 810 intranasal stand alone unitDevice

    Daily at home intranasal "sham" NIR stimulation sessions, 25 minutes in duration, 4 days each week.

Study groups in NCT03551392
Study groupRoleWhat they receive
NIR -Older AdultActive comparatorOlder adult participants receive the Medx Console System and the Vielight 810 intranasal stand alone unit. These interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.
Receives: Device: Medx Console System; Device: Vielight 810 intranasal stand alone unit
No Dose NIR-Older AdultSham comparatorOlder adult participants receive the sham Medx Console System and the sham Vielight 810 intranasal stand alone unit, since the devices deliver no near infrared light. These sham interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week.
Receives: Device: Sham Medx Console System; Device: Sham Vielight 810 intranasal stand alone unit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ARENA, learning and memory change from baseline to post-testing

    Spatial navigation and memory task yields a score consisting of percent time spent in the target quadrant during the probe trial.

    Measured: Baseline to one-week post intervention (approx Week 14)

Secondary outcomes (2)

  1. NIH Examiner, Verbal Fluency Domain Score change from baseline

    The Verbal Fluency domain from the NIH Examiner involves speeded production of letter and semantic cued words. Verbal fluency composite score can range from -3.0 to 3.0, with higher scores corresponding to better fluency performance and negative scores indicating impairment. A change score will be calculated by subtracting the baseline scores from the post test scores.

    Measured: Change in baseline to one-week post intervention (approx Week 14)

  2. NIH Examiner, Working Memory Domain score change from baseline

    Computer based battery of working memory tasks that yields a composite score based on Dot Counting total score and d-prime measures from the N-back task. Composite score ranges from -3.0 to 3.0, with higher scores corresponding to better working memory performance. A change score will be calculated by subtracting the baseline scores from the post test scores.

    Measured: Change in baseline to one-week post intervention (approx Week 14)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2018
  2. Study start26 Jun 2019
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a blinded parallel group sham controlled pilot trial, with half the participants randomized to the real NIR treatment and half to the sham treatment condition.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03551392
Sponsor's protocol ID
IRB201801152
Other IDs
OCR18061, PRO00020250
Status last verified
Aug 2026
First submitted
29 May 2018
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Medx Console System and Vielight 810 intranasal stand alone unit in people with Aging, run by University of Florida at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ARENA, learning and memory change from baseline to post-testing (time frame: Baseline to one-week post intervention (approx Week 14)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03551392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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Pilot Intervention With Near Infrared Stimulation | AzTrials