NCT06688357

Revitalize Cognition: Near Infrared Stimulation in Parkinson Patients

Revitalize Cognition: A Proof of Concept Study Using Transcranial Near Infrared Stimulation in Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 62 Years – 89 Years
• Healthy volunteers: Not accepted

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

Detailed description

There are few validated approaches for minimizing cognitive changes that frequently accompany Parkinson disease (PD). The goal of this study is to test a novel and potentially high impact brain stimulation approach for enhancing cognitive, mood, and motor symptoms in individuals with PD. This brain stimulation approach involves transcranial delivery of near infrared (NIR) light, which is painless and undetectable, and enhances brain metabolism. This NIR stimulation approach is also known as photobiomodulation (PMB). The study builds on the following premises: Mitochondrial dysfunction has been implicated in both familial and nonfamilial Parkinson disease. NIR stimulation is a novel intervention for enhancing mitochondrial energy metabolism; Indeed, research in cellular and animal models suggests that application of light in red (630-700nm) and near infrared wavelengths (808-904nm) is neuroprotective and improves mitochondrial function by promoting increased production of intracellular adenosine triphosphate (ATP), important for cellular metabolism and oxygenation. Findings of positive effects of NIR stimulation on motor and cognitive symptoms in animal models of PD, both rodent and macaques. In these animal studies, strong evidence supports neuroprotective and 'rescue' effects of NIR stimulation from MPTP-induced neurodegeneration, including preservation of locomotor activity and midbrain dopaminergic neurons. It is unclear whether similar beneficial effects might be afforded humans with idiopathic Parkinson disease (PD). As such, the goal is to conduct a proof-of-concept randomized control pilot study to determine feasibility, acceptability and efficacy of a NIR stimulation protocol in individuals with Parkinson disease (PD). The intervention will involve six sessions over a 2-week period, in which active or sham stimulation is applied to the head using a delivery system that has been approved as a nonsignificant risk since 2003. The delivery system involves six MedX superluminous light emitting diode clusters positioned on the head in distinct configurations for a total of 40 minutes of stimulation. Dosing was based on a pilot study. The investigators plan to enroll 24 non-demented individuals with PD who will be randomized to active or sham groups. Cognitive, motor, and mood outcomes will be obtained before and after the intervention. An exploratory aim involves neuroimaging changes (1P MRS, resting state fMRI). Outcomes will be obtained during the off-dopamine medication state (i.e., standard overnight withdrawal from dopamine medications). The investigators hope to learn whether NIR stimulation has potential for influencing motor and cognitive symptoms in individuals with PD, with goal of determining effect sizes for a potentially larger randomized clinical trial.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Active NIR-PBM (MedX 1116, MCT502)	Near infrared light was delivered using two MedX Rehab Console systems (MedX Health, 1116). Each MedX console included a control unit and 3 superluminous light emitting diode (LED) clusters. Each LED cluster (3MedX MCT502) consisted of 52 near infrared diodes and 9 visible red diodes. The 9 red diodes were deactivated. The energy delivered by each cluster was 1 joule \[J\]/cm2 in 45 sec at treatment wavelength of 870 nm per each 20 min. The LED cluster has an irradiance of 22.2 mW/cm2, treats an area of 22.48 cm2, with an energy density of 26.64/cm2 per cluster (total energy of 599J/cluster). During each session, the 6 clusters were arrayed on the scalp in 2 configurations, 20 minutes per array. Each configuration targeted 6 transcranial sites, guided by the 10-20 system, for a total of 12 sites during the 40-min session. Total energy delivered was 599J/cluster X 12 sites = 7188J. Dosing was based on a pilot study. This intervention was given 3 times/week for 2 weeks.
DEVICE	Sham NIR-PBM (MedX 1116, MCT502)	The MedX sham intervention device is identical in all respects to the active device, except that the MedX console and diode clusters were modified to NOT deliver NIR light when turned on. The sham MedX devices were modified to deliver 'warmth', similar to that of the active devices. As with the active condition, a total of six sham interventions were given over a 2-week period, following the identical procedures described in the active condition.

Timeline

• Start date: 2019-06-26
• Primary completion: 2021-02-17
• Completion: 2022-08-15
• First posted: 2024-11-14
• Last updated: 2025-02-17
• Results posted: 2025-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study