N/A Completed N=16 Randomized Double-blind Treatment

Revitalize Cognition: Near Infrared Stimulation in Parkinson Patients

Source: ClinicalTrials.gov NCT06688357 ↗

Enrolled (actual)

Serious AEs

6.3%

Results posted

Feb 2025

Primary outcomePrimary: Fluency Composite From NIH Examiner (Kramer et al., 2014). — 0.334; -0.0287 z-score — p=.077

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Fluency Composite From NIH Examiner (Kramer et al., 2014).	0.334; -0.0287	.077
PRIMARY ARENA Spatial Navigation Memory Task-Learning Composite	-0.1088; -0.8495	.159
PRIMARY ARENA Spatial Navigation Memory Task - Total Composite	-0.1750; -0.4478	.503
PRIMARY Gait Stride Length Variability	-0.388; .854	0.08
SECONDARY Working Memory Composite From the NIH Examiner (Kramer et al., 2014)	0.1491; -0.1253	.149
SECONDARY Rey Auditory Verbal Learning Test (RAVLT)	2.38; 0.57	.104
SECONDARY Negative Affect Scale From the Emotion Module of the NIH Toolbox	-1.95; -.922	.614

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06688357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.