Pilot Intervention With Near Infrared Stimulation

• ClinicalTrials.gov Identifier: NCT03551392
• Recruitment Status: Recruiting
• First Posted: June 11, 2018
• Last Update Posted: September 16, 2022
• Sponsor: University of Florida
• Collaborators: McKnight Brain Research Foundation; University of Arizona
• Information provided by (Responsible Party): University of Florida

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.

Condition or disease	Intervention/treatment	Phase
Aging; Parkinson Disease	Device: Medx Console System; Device: Sham Medx Console System; Device: Vielight 810 intranasal stand alone unit; Device: Sham Vielight 810 intranasal stand alone unit	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: Research assistants who administer pre and post measures will be masked, as well as participants who receive the intervention.
• Primary Purpose: Treatment
• Official Title: Pilot Intervention With Near Infrared Stimulation: Revitalizing Cognition in Older Adults and Those With Parkinson Disease
• Actual Study Start Date: June 26, 2019
• Estimated Primary Completion Date: May 5, 2023
• Estimated Study Completion Date: May 5, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Device: 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.; Other Names: Low Level Light Therapy; Photobiomodulation; Transcranial Near Infrared Stimulation; Device: Vielight 810 intranasal stand alone unit; Daily at home intranasal NIR stimulation sessions, 25 minutes in duration, 4 days each week.
Sham Comparator: 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.	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.; Device: Sham Vielight 810 intranasal stand alone unit; Daily at home intranasal "sham" NIR stimulation sessions, 25 minutes in duration, 4 days each week.
Active Comparator: NIR -Parkinson; 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.	Device: 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.; Other Names: Low Level Light Therapy; Photobiomodulation; Transcranial Near Infrared Stimulation; Device: Vielight 810 intranasal stand alone unit; Daily at home intranasal NIR stimulation sessions, 25 minutes in duration, 4 days each week.
Sham Comparator: No Dose NIR-Parkinson; 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.	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.; Device: Sham Vielight 810 intranasal stand alone unit; Daily at home intranasal "sham" NIR stimulation sessions, 25 minutes in duration, 4 days each week.

Outcome Measures

Primary Outcome Measures :

1. ARENA, learning and memory change from baseline to post-testing [ Time Frame: Baseline to one-week post intervention (approx Week 14) ]
   Spatial navigation and memory task yields a score consisting of percent time spent in the target quadrant during the probe trial.

Secondary Outcome Measures :

1. NIH Examiner Executive Composite Score change from baseline to post-testing [ Time Frame: Change in baseline to one week post intervention (approx Week 14) ]
   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.
2. NIH Toolbox Emotion Negative Affect Scale change from baseline to post-testing [ Time Frame: Baseline to one-week post-intervention (approx Week 14) ]
   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.
3. NIH Examiner, Verbal Fluency Domain Score change from baseline [ Time Frame: Change in baseline to one-week post intervention (approx Week 14) ]
   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.
4. NIH Examiner, Working Memory Domain score change from baseline [ Time Frame: Change in baseline to one-week post intervention (approx Week 14) ]
   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.
5. NIH Examiner, Cognitive Control Domain score change from baseline to post-testing [ Time Frame: Change in baseline to one-week post intervention (approx Week 14) ]
   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.
6. NIH Toolbox Emotion-Psychological Well Being Scale change from baseline [ Time Frame: Change in baseline to one-week post intervention (approx Week 14) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 89 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Dawn Bowers, Ph.D.; 352-273-5270; dawnbowers@Phhp.ufl.edu

Contact: Adam Woods, Ph.D.; 352-294-5842; ajwoods@phhp.ufl.edu

Locations

United States, Arizona

University of Arizona; Recruiting

Tucson, Arizona, United States, 85721

United States, Florida

University of Florida; Recruiting

Gainesville, Florida, United States, 32611

Sponsors and Collaborators

University of Florida

McKnight Brain Research Foundation

University of Arizona

Investigators

• Principal Investigator: Dawn Bowers, Ph.D.; University of Florida
• Principal Investigator: Adam Woods, Ph.D.; University of Florida
• Principal Investigator: Gene Alexander, Ph.D.; University of Arizona

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03551392
• Other Study ID Numbers: IRB201801152; OCR18061 ( Other Identifier: University of Florida ); PRO00020250 ( Other Identifier: UFIRST )
• First Posted: June 11, 2018
• Last Update Posted: September 16, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by University of Florida:

Cognitive Aging; Photobiomodulation; Low Level Light Therapy; Near Infrared (NIR) Light; Neuromodulation

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases