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Revitalize Cognition: Near Infrared Stimulation in Older Adults

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ClinicalTrials.gov Identifier: NCT02582593
Recruitment Status : Recruiting
First Posted : October 21, 2015
Last Update Posted : January 27, 2021
Sponsor:
Collaborators:
FL DEPT OF HLTH ED ETHEL MOORE ALZHEIMER
Parkinson's Foundation
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE October 16, 2015
First Posted Date  ICMJE October 21, 2015
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE December 2015
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
NIH Examiner Battery, Executive Composite changes from baseline to post-testing [ Time Frame: Change in baseline to approximately week 3 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
  • Loewenstein-Acevedo Scale of Semantic Interference and Learning (LASSI-L) Free Delayed Recall changes from baseline to post-testing [ Time Frame: Change in baseline to approximately week 3 ]
    The LASSI-L is a 15 item word list learning task that instructs a participant to remember a list of common words (fruits, musical instruments, or articles of clothing with 5 words per category) after interference and delay. The delayed recall score ranges from 0-15. A change score will be calculated by subtracting the baseline scores from the post-test scores.
  • NIH Toolbox Emotion Psychological Wellbeing Scale changes from baseline to post-testing [ Time Frame: Change in baseline to approximately week 3 ]
    The Psychological Wellbeing Scale from the NIH Toolbox Emotion module Wellbeing Scale results in T-scores (mean=50, SD=10) for categories such as positive affect, life satisfaction, and meaning and purpose. Scores below 40 indicate low levels of wellbeing and scores above 60 indicating high levels of wellbeing. Change scores will be calculated by subtracting the baseline scores from the post-test scores.
  • NIH Toolbox Emotion Negative Affect Scale changes from baseline to post-testing [ Time Frame: Change in baseline to approximately week 3 ]
    The Negative Affect Scale from the NIH Toolbox Emotion module results in T-scores (mean=50, SD=10) for categories such as anger, sadness, and apathy. Scores below 40 indicate low levels of negative affect and scores above 60 indicate high levels of negative affect. Change scores will be calculated by subtracting the baseline scores from the post-test scores.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Revitalize Cognition: Near Infrared Stimulation in Older Adults
Official Title  ICMJE Revitalize Cognition: A Proof of Concept Study Using Transcranial Near Infrared Stimulation in Older Adults
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.
Detailed Description

There is a dearth of clinically meaningful treatment options at this point in time for individuals who are at increased risk for transitioning to dementia, particularly those with the amnestic variant of mild cognitive impairment (aMCI). While waiting for causative cures and preventive approaches, investigators are faced with the task of identifying modifying therapies that might alter the course or slow down the transition from normal cognition to MCI to dementia.

The proposed study hopes to contribute to this mission by testing the viability of a different type of intervention, one involving transcranial delivery of near-infrared (NIR) wavelengths (808-904nm). Near-infrared stimulation is safe, non-invasive and appears to improve mitochondrial function by promoting increased production of intracellular adenosine triphosphate (ATP) and possibly improved blood flow. Perhaps most compelling are recent findings of reduced beta-amyloid and neurofibrillary tangles in transgenic Alzheimer's mouse models after exposure to real vs sham transcranial NIR stimulation. Preliminary human involving traumatic brain injury (TBI), stroke, and young adult populations have also been promising in terms of positive effects of NIR on cognition.

The overall goal of the present study is to learn whether this unconventional NIR stimulation approach has potential for improving cognition in older adults. To do so, investigators will conduct a randomized sham controlled pilot trial. The intervention will involve six sessions, over a 2-week period in which real or sham stimulation is transcranially applied using a delivery system that has been FDA-approved as a nonsignificant risk since 2003. Researchers hope to learn whether NIR stimulation, relative to sham, has positive effects on cognition and mood in older adults.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Aging
Intervention  ICMJE
  • Device: MedX 1116 Rehab Console
    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.
    Other Names:
    • Photobiomodulation
    • Low Level Light Therapy
    • Transcranial Near Infrared Stimulation
  • Device: Sham MedX 1116 Rehab Console
    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.
    Other Name: Placebo
Study Arms  ICMJE
  • Active Comparator: Cognitively Normal Group NIR
    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.
    Intervention: Device: MedX 1116 Rehab Console
  • Sham Comparator: Cognitively Normal Group - Sham
    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.
    Intervention: Device: Sham MedX 1116 Rehab Console
  • Active Comparator: Amnestic MCI Groups - Amnestic and Nonamnestic NIR
    Transcranial Near Infrared Stimulation for amnestic and nonamnestic 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.
    Intervention: Device: MedX 1116 Rehab Console
  • Sham Comparator: Amnestic MCI Groups - Amnestic and Nonamnestic - Sham
    Amnestic and Nonamnestic 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.
    Intervention: Device: Sham MedX 1116 Rehab Console
  • Active Comparator: Parkinson Disease Group NIR
    Transcranial Near Infrared Stimulation for Parkinson Disease 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.
    Intervention: Device: MedX 1116 Rehab Console
  • Sham Comparator: Parkinson Disease Group Sham
    Parkinson Disease 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.
    Intervention: Device: Sham MedX 1116 Rehab Console
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2021)
180
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2015)
70
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 8th 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

Exclusion criteria

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 62 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dawn Bowers, Ph.D. 352-392-3450 dawnbowers@phhp.ufl.edu
Contact: Paul Mangal, M.S. 352-392-3450 pmangal@phhp.ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02582593
Other Study ID Numbers  ICMJE IRB201400128
6AZ15 ( Other Grant/Funding Number: FL DEPT OF HLTH ED ETHEL MOORE ALZHEIMER )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE
  • FL DEPT OF HLTH ED ETHEL MOORE ALZHEIMER
  • Parkinson's Foundation
Investigators  ICMJE
Principal Investigator: Dawn Bowers, Ph.D. University of Florida
PRS Account University of Florida
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP