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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 23, 2020
Sponsor:
Collaborators:
FL DEPT OF HLTH ED ETHEL MOORE ALZHEIMER
Parkinson's Foundation
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Aging Device: MedX 1116 Rehab Console Device: Sham MedX 1116 Rehab Console Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Revitalize Cognition: A Proof of Concept Study Using Transcranial Near Infrared Stimulation in Older Adults
Study Start Date : December 2015
Estimated Primary Completion Date : September 16, 2020
Estimated Study Completion Date : September 16, 2020

Arm Intervention/treatment
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.
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

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.
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

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.
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

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.
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

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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   62 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582593


Contacts
Layout table for location contacts
Contact: Dawn Bowers, Ph.D. 352-392-3450 dawnbowers@phhp.ufl.edu
Contact: Paul Mangal, M.S. 352-392-3450 pmangal@phhp.ufl.edu

Locations
Layout table for location information
United States, Florida
The Center for Movement Disorders and Neurorestoration Recruiting
Gainesville, Florida, United States, 32607
Contact: Dawn Bowers, Ph.D.    352-273-6152    dawnbowers@phhp.ufl.edu   
The Village Retirement Community Recruiting
Gainesville, Florida, United States, 32653
Contact: Dawn Bowers, Ph.D.    352-392-3450    dawnbowers@phhp.ufl.edu   
Contact: Michael Marsiske, Ph.D    352-392-3450    marsiske@phhp.ufl.edu   
Principal Investigator: Dawn Bowers, Ph.D.         
Sub-Investigator: Michael Marsiske, Ph.D.         
Sponsors and Collaborators
University of Florida
FL DEPT OF HLTH ED ETHEL MOORE ALZHEIMER
Parkinson's Foundation
Investigators
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Principal Investigator: Dawn Bowers, Ph.D. University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02582593    
Other Study ID Numbers: IRB201400128
6AZ15 ( Other Grant/Funding Number: FL DEPT OF HLTH ED ETHEL MOORE ALZHEIMER )
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: September 2019

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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
Keywords provided by University of Florida:
Cognitive Aging
Neuromodulation
Low Level Light Therapy
Near Infrared Light
Neurostimulation