Pilot Intervention With Near Infrared Stimulation

NCT ID: NCT03551392

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2026-04-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NIR -Older Adult

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.

Group Type: ACTIVE_COMPARATOR

Medx Console System

Intervention Type: 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.

Vielight 810 intranasal stand alone unit

Intervention Type: DEVICE

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

No Dose NIR-Older Adult

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.

Group Type: SHAM_COMPARATOR

Sham Medx Console System

Intervention Type: 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.

Sham Vielight 810 intranasal stand alone unit

Intervention Type: DEVICE

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

Interventions

Medx Console System

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.

Intervention Type: DEVICE

Sham Medx Console System

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.

Intervention Type: DEVICE

Vielight 810 intranasal stand alone unit

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

Intervention Type: DEVICE

Sham Vielight 810 intranasal stand alone unit

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

Intervention Type: DEVICE

Other Intervention Names

Low Level Light Therapy; Photobiomodulation; Transcranial Near Infrared Stimulation

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McKnight Brain Research Foundation

UNKNOWN

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn Bowers, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Adam Woods, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Gene Alexander, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Site Status: RECRUITING

University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dawn Bowers, Ph.D.

Role: CONTACT

dawnbowers@Phhp.ufl.edu

352-273-5270

Adam Woods, Ph.D.

Role: CONTACT

ajwoods@phhp.ufl.edu

352-294-5842

Other Identifiers

OCR18061

Identifier Type: OTHER

Identifier Source: secondary_id

PRO00020250

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201801152

Identifier Type: -

Identifier Source: org_study_id