Pilot Intervention With Near Infrared Stimulation

Parkinson Disease Clinical Trial

Official title:

Pilot Intervention With Near Infrared Stimulation: Revitalizing Cognition in Older Adults and Those With Parkinson Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03551392
• Other study ID #: IRB201801152
• Secondary ID: OCR18061PRO00020
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2019
• Est. completion date: October 5, 2024

Study information

• Verified date: July 2023
• Source: University of Florida
• Contact: Dawn Bowers, Ph.D.
• Phone: 352-273-5270
• Email: dawnbowers[@]Phhp.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: October 5, 2024
• Est. primary completion date: October 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Parkinson Disease

Intervention

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.
• 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.
• Vielight 810 intranasal stand alone unit
Daily at home intranasal NIR stimulation sessions, 25 minutes in duration, 4 days each week.
• Sham Vielight 810 intranasal stand alone unit
Daily at home intranasal "sham" NIR stimulation sessions, 25 minutes in duration, 4 days each week.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	University of Arizona	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	McKnight Brain Research Foundation, University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to one-week post intervention (approx Week 14)
Secondary	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.	Change in baseline to one week post intervention (approx Week 14)
Secondary	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.	Baseline to one-week post-intervention (approx Week 14)
Secondary	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.	Change in baseline to one-week post intervention (approx Week 14)
Secondary	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.	Change in baseline to one-week post intervention (approx Week 14)
Secondary	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.	Change in baseline to one-week post intervention (approx Week 14)
Secondary	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.	Change in baseline to one-week post intervention (approx Week 14)