Pilot Intervention With Near Infrared Stimulation

Not Applicable

Recruiting

• Conditions: Parkinson Disease; Aging
• Interventions: Device: Sham Medx Console System; Device: Medx Console System; Device: Sham Vielight 810 intranasal stand alone unit; Device: Vielight 810 intranasal stand alone unit

• Registration Number: NCT03551392
• Lead Sponsor: University of Florida

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-06-11
• Study Start: 2019-06-26
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-10-05
• Study Completion: 2024-10-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Dose NIR-Older Adult	Sham Vielight 810 intranasal stand alone unit	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.
No Dose NIR-Older Adult	Sham Medx Console System	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.
No Dose NIR-Parkinson	Sham Vielight 810 intranasal stand alone unit	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.
NIR -Older Adult	Vielight 810 intranasal stand alone unit	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.
NIR -Older Adult	Medx Console System	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.
NIR -Parkinson	Medx Console System	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.
NIR -Parkinson	Vielight 810 intranasal stand alone unit	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.
No Dose NIR-Parkinson	Sham Medx Console System	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.

Primary Outcome Measures

Name	Time	Method
ARENA, learning and memory change from baseline to post-testing	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

Name	Time	Method
NIH Toolbox Emotion-Psychological Well Being Scale change from baseline	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.
NIH Examiner Executive Composite Score change from baseline to post-testing	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.
NIH Examiner, Verbal Fluency Domain Score change from baseline	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.
NIH Examiner, Working Memory Domain score change from baseline	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.
NIH Examiner, Cognitive Control Domain score change from baseline to post-testing	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.
NIH Toolbox Emotion Negative Affect Scale change from baseline to post-testing	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.

Trial Locations

Locations (2)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States