Pilot Intervention With Near Infrared Stimulation

NCT03551392 | Recruiting FDA Device

• 3 other identifiers: IRB201801152OCR18061PRO00020250
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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 cognitive and mood performance.

Conditions

Aging

Keywords

Cognitive Aging; Photobiomodulation; Low Level Light Therapy; Near Infrared (NIR) Light; Neuromodulation

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• NIH Examiner, Verbal Fluency Domain Score change from baseline

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

• NIH Examiner, Working Memory Domain score change from baseline

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

• NIH Examiner, Cognitive Control Domain score change from baseline to post-testing

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

• NIH Toolbox Emotion Negative Affect Scale change from baseline to post-testing

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

• NIH Toolbox Emotion-Psychological Well Being Scale change from baseline

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

Study Arms (2)

NIR -Older Adult

ACTIVE COMPARATOR

Older 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.

Device: Medx Console System; Device: Vielight 810 intranasal stand alone unit

No Dose NIR-Older Adult

SHAM COMPARATOR

Older 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.

Device: Sham Medx Console System; Device: Sham Vielight 810 intranasal stand alone unit

Interventions

Medx Console System DEVICE

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.

Also known as: Low Level Light Therapy, Photobiomodulation, Transcranial Near Infrared Stimulation

NIR -Older Adult

Sham Medx Console System DEVICE

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.

No Dose NIR-Older Adult

Vielight 810 intranasal stand alone unit DEVICE

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

NIR -Older Adult

Sham Vielight 810 intranasal stand alone unit DEVICE

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

No Dose NIR-Older Adult

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Florida: lead
• McKnight Brain Research Foundation: collaborator
• University of Arizona: collaborator

Study Sites (2)

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Dawn Bowers, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

• Adam Woods, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

• Gene Alexander, Ph.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn Bowers, Ph.D.

CONTACT

352-273-5270; dawnbowers@Phhp.ufl.edu

Adam Woods, Ph.D.

CONTACT

352-294-5842; ajwoods@phhp.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Research assistants who administer pre and post measures will be masked, as well as participants who receive the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a blinded parallel group sham controlled pilot trial, with half the participants in each group randomized to the real NIR treatment and half to the sham treatment condition.

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 11, 2018
• Study Start: June 26, 2019
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)