Revitalize Cognition: Near Infrared Stimulation in Older Adults

NCT02582593 | Completed Results FDA Device

• 3 other identifiers: IRB2014001286AZ15PF-IMP-1938
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

Changes in mood and cognition are common in older adulthood. Some studies have suggested that transcranial application of near-infrared (NIR) light may have enhancing effects on cognitive and mood status in young adults and individuals with traumatic brain injury. This effect has not been examined in older adults. This study will involve a randomized sham-controlled trial to learn whether NIR stimulation improves cognition and mood in older adults, relative to sham treated controls. Aim 4 of this study (Parkinson Specific) is registered separately under NCT06688357

Conditions

Aging

Keywords

Cognitive Aging; Neuromodulation; Low Level Light Therapy; Near Infrared Light; Neurostimulation

Outcome Measures

Primary Outcomes (1)

• NIH Examiner Battery, Executive Composite Changes From Baseline to Post-testing

  Computer-based battery of executive functioning tests which yields a total or "composite" score to represent global executive functioning. Executive composite scores can range from -3.0 to 3.0, with higher scores corresponding to better executive functioning, and negative scores indicating impairment. A change score will be calculated by subtracting the baseline scores from the post-test scores.

  Change in baseline to approximately week 3

Secondary Outcomes (3)

• Composite Learning-Retention Score From ARENA Task

  Change in baseline to approximately week 3

• NIH Toolbox Emotion Psychological Wellbeing Scale Changes From Baseline to Post-testing

  Change in baseline to approximately week 3 (Post - Baseline)

• NIH Toolbox Emotion Negative Affect Scale Changes From Baseline to Post-testing

  Change from baseline to approximately week 3 (Post Intervention - Baseline)

Study Arms (2)

Older Adult Group NIR

ACTIVE COMPARATOR

Transcranial Near Infrared Stimulation for cognitively normal participants who will attend a total of 6 treatment sessions over a two week period. During each session, stimulation via light emitting diode clusters will occur for a total of 60 minutes. Four light emitting diode (LED) clusters will be applied in 3 distinct configurations. There will be 20 minutes of stimulation at each of these 3 configurations. Each configuration will target 4 sites, for a total of 12 sites over the course of the 60 minute session. The power density used will be 500 milliwatts (mW) with a cumulative fluence (energy density) of 312 Joules/cm2 (26 J/cm2 applied at 12 sites). It is estimated that approximately 6 Joules/cm2 will reach the cortex with each daily treatment.

Device: MedX 1116 Rehab Console

Older Adult Group - Sham

SHAM COMPARATOR

Cognitively Normal Participants in the sham control group will undergo identical procedures as the intervention group - screening, baseline testing, and LED cluster placement procedures. However, during the near infrared (NIR) session, the MedX console will not be turned on and no active stimulation will be applied.

Device: Sham MedX 1116 Rehab Console

Interventions

MedX 1116 Rehab Console DEVICE

This intervention makes use of transcranially applied near infrared light using light emitting diodes. Near infrared light will be applied to the scalp for a period of 1 hour at each session. A total of six session will be held.

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

Older Adult Group NIR

Sham MedX 1116 Rehab Console DEVICE

This intervention makes use of sham transcranially applied near infrared light using light emitting diodes. Light emitting diodes (but not near-infrared light) will be applied to the scalp for a period of 1 hour at each session. A total of six session will be held.

Also known as: Placebo

Older Adult Group - Sham

Eligibility Criteria

• Age: 62 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 62 years or above
• Able to provide informed consent and perform cognitive and mood measures on a computer
• Willingness to be randomized to Sham or Real intervention
• Can devote 2 weeks to the intervention, and additional time for pre and post testing
• th grade education and ability to read on 8th grade level based on scores on the Wechsler Test of Adult Reading (WTAR) or the Wide Range Achievement Test-IV (WRAT-IV); or a reading test at 14 pt. text
• On stable doses of major medications; Since some older adults with 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.
• Willingness to allow a study partner (spouse, family member, friend) to answer questions about their cognitive, mood, and other behaviors

You may not qualify if:

• Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental cognitive tasks or neuropsychological assessment
• Unstable and uncontrolled medical conditions (metabolic encephalopathy, HIV, moderate to severe kidney or liver disease)
• 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.
• Evidence of potential dementia (e.g., scores \< 24 on the Mini Mental State Exam (MMSE), or \< 20 on the Montreal Cognitive Assessement (MoCA), or less than 5th percentile on the Dementia Rating Scale-2 (DRS-2)
• 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. This will be assessed using the Mental Health Screen v.3 (Carroll \& McGinley), a modification of the Structured Clinical Interview for DSM-IV psychiatric disorders. We are 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 cancer
• Previous participation in a cognitive training study within the last 3 months or current involvement in another study at VITAL or ReVITALIZE, or another study involving cognitive training or intervention at the time of participation

Sponsors & Collaborators

• University of Florida: lead
• Ed and Ethel Moore Alzheimer's Disease Research Program: collaborator

Study Sites (2)

The Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

Location

The Village Retirement Community

Gainesville, Florida, 32653, United States

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Limitations and Caveats

This was pilot proof of concept study designed to determine potential effect sizes for a larger study. Small sample size was major limitation. Instead of using overall executive composite score as from the NIH Examiner as major outcome, we recommend breaking down executive function into its components (working memory, fluency) in future studies.

Results Point of Contact

• Title: Dawn Bowers, Ph.D.
• Organization: University of Florida

dawnbowers@phhp.ufl.edu

(352) 273-6617

Study Officials

• Dawn Bowers, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, sham controlled

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 21, 2015
• Study Start: December 18, 2015
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: February 19, 2025
• Results First Posted: February 19, 2025

Record last verified: 2025-01

Locations

US (2)