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Pilot Intervention With Near Infrared Stimulation

Primary Purpose

Aging, Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medx Console System
Sham Medx Console System
Vielight 810 intranasal stand alone unit
Sham Vielight 810 intranasal stand alone unit
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring Cognitive Aging, Photobiomodulation, Low Level Light Therapy, Near Infrared (NIR) Light, Neuromodulation

Eligibility Criteria

65 Years - 89 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Additional criteria for participants in Parkinson group

  • Participants must have a diagnosis of idiopathic Parkinson's disease by a movement disorders specialist based on UK Brain Bank criteria
  • No previous history of brain surgery (DBS, pallidotomy, thalamotomy, or fetal cell implants).
  • May have difficulties with activities of daily living, but this is due to physical symptoms of Parkinson disease and not because of cognitive problems
  • Hoehn-Yahr staging between .5 and 3.5

Sites / Locations

  • University of ArizonaRecruiting
  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

NIR -Older Adult

No Dose NIR-Older Adult

NIR -Parkinson

No Dose NIR-Parkinson

Arm Description

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.

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.

Participants with Parkinson disease 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.

Participants with Parkinson disease 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

NIH Examiner Executive Composite Score change from baseline to post-testing
Computer based battery of executive function 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.
NIH Toolbox Emotion Negative Affect Scale change from baseline to post-testing
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. Change scores will be calculated by subtracting the baseline scores from the post-test scores.
NIH Examiner, Verbal Fluency Domain Score change from baseline
The Verbal Fluency domain from the NIH Examiner involves speeded production of letter and semantic cued words. Verbal fluency composite score can range from -3.0 to 3.0, with higher scores corresponding to better fluency performance and negative scores indicating impairment. A change score will be calculated by subtracting the baseline scores from the post test scores.
NIH Examiner, Working Memory Domain score change from baseline
Computer based battery of working memory tasks that yields a composite score based on Dot Counting total score and d-prime measures from the N-back task. Composite score ranges from -3.0 to 3.0, with higher scores corresponding to better working memory performance. A change score will be calculated by subtracting the baseline scores from the post test scores.
NIH Examiner, Cognitive Control Domain score change from baseline to post-testing
The Cognitive Control domain from the NIH Examiner yields a composite score based on individual scores from the Flanker task, the Continuous Performance task, and the Set-Shifting task. Composite score ranges from -3.0 to 3.0, with higher scores corresponding to better cognitive control performance. A change score will be calculated by subtracting the baseline scores from the post test scores.
NIH Toolbox Emotion-Psychological Well Being Scale change from baseline
The Psychological Well-being Scale from the NIH Toolbox Emotion module results in T-scores (mean=50, SD=10) for categories such general life satisfaction, meaning and purpose, and positive affect. Scores below 40 indicate low levels of positive affect. Change scores will be calculated by subtracting the baseline scores from the post-test scores.

Full Information

First Posted
May 29, 2018
Last Updated
July 24, 2023
Sponsor
University of Florida
Collaborators
McKnight Brain Research Foundation, University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT03551392
Brief Title
Pilot Intervention With Near Infrared Stimulation
Official Title
Pilot Intervention With Near Infrared Stimulation: Revitalizing Cognition in Older Adults and Those With Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
October 5, 2024 (Anticipated)
Study Completion Date
October 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
McKnight Brain Research Foundation, University of Arizona

4. Oversight

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The current study will test whether age-related cognitive and mood changes in older adults and those with Parkinson disease 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 pilot study of the efficacy of NIR stimulation for enhancing cognition and mood in nondemented older adults including individuals with Parkinson disease. 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 and those with Parkinson disease will be affected by near infrared (NIR) stimulation. The study team will randomize older adults and those with Parkinson disease into treatment groups and evaluate neuroimaging and cognitive outcome measures, before and after an 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Parkinson Disease
Keywords
Cognitive Aging, Photobiomodulation, Low Level Light Therapy, Near Infrared (NIR) Light, Neuromodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Research assistants who administer pre and post measures will be masked, as well as participants who receive the intervention.
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIR -Older Adult
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Dose NIR-Older Adult
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
NIR -Parkinson
Arm Type
Active Comparator
Arm Description
Participants with Parkinson disease 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.
Arm Title
No Dose NIR-Parkinson
Arm Type
Sham Comparator
Arm Description
Participants with Parkinson disease 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.
Intervention Type
Device
Intervention Name(s)
Medx Console System
Other Intervention Name(s)
Low Level Light Therapy, Photobiomodulation, Transcranial Near Infrared Stimulation
Intervention Description
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
Intervention Name(s)
Sham Medx Console System
Intervention Description
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
Intervention Name(s)
Vielight 810 intranasal stand alone unit
Intervention Description
Daily at home intranasal NIR stimulation sessions, 25 minutes in duration, 4 days each week.
Intervention Type
Device
Intervention Name(s)
Sham Vielight 810 intranasal stand alone unit
Intervention Description
Daily at home intranasal "sham" NIR stimulation sessions, 25 minutes in duration, 4 days each week.
Primary Outcome Measure Information:
Title
ARENA, learning and memory change from baseline to post-testing
Description
Spatial navigation and memory task yields a score consisting of percent time spent in the target quadrant during the probe trial.
Time Frame
Baseline to one-week post intervention (approx Week 14)
Secondary Outcome Measure Information:
Title
NIH Examiner Executive Composite Score change from baseline to post-testing
Description
Computer based battery of executive function 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.
Time Frame
Change in baseline to one week post intervention (approx Week 14)
Title
NIH Toolbox Emotion Negative Affect Scale change from baseline to post-testing
Description
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. Change scores will be calculated by subtracting the baseline scores from the post-test scores.
Time Frame
Baseline to one-week post-intervention (approx Week 14)
Title
NIH Examiner, Verbal Fluency Domain Score change from baseline
Description
The Verbal Fluency domain from the NIH Examiner involves speeded production of letter and semantic cued words. Verbal fluency composite score can range from -3.0 to 3.0, with higher scores corresponding to better fluency performance and negative scores indicating impairment. A change score will be calculated by subtracting the baseline scores from the post test scores.
Time Frame
Change in baseline to one-week post intervention (approx Week 14)
Title
NIH Examiner, Working Memory Domain score change from baseline
Description
Computer based battery of working memory tasks that yields a composite score based on Dot Counting total score and d-prime measures from the N-back task. Composite score ranges from -3.0 to 3.0, with higher scores corresponding to better working memory performance. A change score will be calculated by subtracting the baseline scores from the post test scores.
Time Frame
Change in baseline to one-week post intervention (approx Week 14)
Title
NIH Examiner, Cognitive Control Domain score change from baseline to post-testing
Description
The Cognitive Control domain from the NIH Examiner yields a composite score based on individual scores from the Flanker task, the Continuous Performance task, and the Set-Shifting task. Composite score ranges from -3.0 to 3.0, with higher scores corresponding to better cognitive control performance. A change score will be calculated by subtracting the baseline scores from the post test scores.
Time Frame
Change in baseline to one-week post intervention (approx Week 14)
Title
NIH Toolbox Emotion-Psychological Well Being Scale change from baseline
Description
The Psychological Well-being Scale from the NIH Toolbox Emotion module results in T-scores (mean=50, SD=10) for categories such general life satisfaction, meaning and purpose, and positive affect. Scores below 40 indicate low levels of positive affect. Change scores will be calculated by subtracting the baseline scores from the post-test scores.
Time Frame
Change in baseline to one-week post intervention (approx Week 14)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 Additional criteria for participants in Parkinson group Participants must have a diagnosis of idiopathic Parkinson's disease by a movement disorders specialist based on UK Brain Bank criteria No previous history of brain surgery (DBS, pallidotomy, thalamotomy, or fetal cell implants). May have difficulties with activities of daily living, but this is due to physical symptoms of Parkinson disease and not because of cognitive problems Hoehn-Yahr staging between .5 and 3.5
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dawn Bowers, Ph.D.
Phone
352-273-5270
Email
dawnbowers@Phhp.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Woods, Ph.D.
Phone
352-294-5842
Email
ajwoods@phhp.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Bowers, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Woods, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gene Alexander, Ph.D.
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Intervention With Near Infrared Stimulation

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