Revitalize Cognition: Near Infrared Stimulation in Parkinson Patients

Completed · Not applicable · Has a placebo group

Conditions studied: Parkinson Disease

In brief

The overall goal of this pilot, proof of concept study is to test a novel, relatively low cost, low risk and potentially high impact intervention for cognitive and motor symptoms associated with idiopathic Parkinson Disease. The intervention involves transcranial delivery of near infrared (NIR) light, aka as photobiomodulation (PBM). This pilot randomized controlled trial will examine whether NIR stimulation influences cognitive, mood, and motor symptoms in Parkinson patients relative to a sham treated group. The goal is to determine effect sizes for a potentially larger study. Aims 1-3 of this study (Older Adult Specific) is registered separately under NCT02582593

Key facts

Study ID

NCT06688357

Run by

University of Florida

People needed

23

Starts

2019-06-26

Expected to finish

2022-08-15

Last updated by the study team

2025-02-17

Who can join

Age: 62 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of idiopathic Parkinson disease by movement disorder neurologist using UK Brain Bank criteria
• Early-mid stage of disease severity
• Willingness to undergo baseline and post-intervention 'off' their normal dopamine medications
• Between 62 and 89 years of age
• 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); ability to see 14 pt. text
• On stable doses of major medications for at least two months

You may not qualify if…

• History of brain abnormalities/ neurological disorders affecting cognition other than PD; No history of brain surgery
• Evidence of potential dementia based on cognitive screening (e.g., scores < 5th %ile on the Montreal Cognitive Assessement (MoCA) or the Dementia Rating Scale-2 (DRS-2) based on appropriate age, education and sex norms.
• Use of psychotics, sedatives or other medications with anticholinergic properties;
• Unstable or uncontrolled medical conditions (e.g.,HIV, severe kidney disease)
• Diagnosis of active cancer
• Use of photosensitive medications within 15 days of intervention
• Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental cognitive tasks or neuropsychological assessment
• 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 investigators 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
• Previous participation in a cognitive training study within the last six months

Where it is running

• Norman Fixel Institute for Neurological Diseases — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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