An interventional study of Active NIR-PBM (MedX 1116, MCT502) and Sham NIR-PBM (MedX 1116, MCT502) in Parkinson Disease, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 62 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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
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.
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Exclusion Criteria:
The Active condition involves baseline testing, two weeks of Near Infrared-Photobiomodulation (NIR-PBM), and post-intervention testing. Cognitive, motor, mood, and neuroimaging outcomes are obtained before (baseline) and after the intervention. During outcome testing, Parkinson patients are evaluated "Off" their normal dopamine medications, following a standard 'overnight' washout. Otherwise, the PD patients were "ON" dopamine medications. The intervention consists of 6 sessions of NIR-photobiomodulation given 3 times/week for 2 weeks. During each session, NIR light is delivered via placement of six MedX LED superluminous diode clusters over the scalp for a total of 40 minutes. During stimulation, participants sit in front of a videomonitor and view nature documentaries (BBC Life series). This is done to standardize behavior during the intervention sessions.
Device: Active NIR-PBM (MedX 1116, MCT502)
The Sham condition is identical in all respects to the Active condition except for use of a "sham" MedX device. The sham device was modified from the original MedX system to not deliver NIR light but was otherwise identical to the active device. Because NIR light is invisible, neither the participants nor interventionists can discern whether active or sham stimulation was being delivered. Otherwise, the Sham condition involved baseline testing (off medication), 2 weeks of sham NIR stimulation, and post-intervention procedures (Off dopamine medication).
Device: Sham 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.
Also known as: Transcranial Near Infrared Stimulation, Photobiomodulation
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.
Also known as: Placebo
Fluency Composite From NIH Examiner (Kramer et al., 2014).
The Fluency Composite is derived from the NIH Examiner, a computer-based battery of executive functioning tasks (Kramer et al., 2014). This composite was chosen due to known verbal fluency difficulties in individuals with Parkinson Disease. Verbal fluency tasks in the NIH Examiner include 2 trials of letter fluency and 2 trials of semantic fluency which are combined to yield a Fluency Composite that ranges from -3.0 to 3.0; higher scores correspond to better fluency performance. A change score is calculated by subtracting the baseline scores from the post-test scores. Greater positive change scores mean better outcome.
Time frame: Baseline and Post-Intervention (2 weeks)
ARENA Spatial Navigation Memory Task-Learning Composite
ARENA is a task of spatial memory-navigation that has been linked to hippocampal function and is a human analogue to the Morris water maze, which has shown sensitivity to NIR stimulation in Alzheimer's transgenic mice. ARENA requires participants to learn and navigate to a hidden target location in a simulated environment. It involves use of a joystick over a series of 8 learning trials and one final probe trial. On each learning trial, the path length and time to reach the target are recorded. The Learning dependent variable is a composite score consisting of mean z-scores for path length and for time to reach the target (Learning Composite). A change score is computed by subtracting the baseline Learning Composite from the post-intervention Learning Composite z-score. Higher scores mean a better outcome.
Time frame: Baseline and Post-Intervention (2 weeks)
ARENA Spatial Navigation Memory Task - Total Composite
ARENA is a computer-based task of spatial memory-navigation that has been linked to hippocampal function and is a human analogue to the Morris water maze. ARENA consists of 9 learning trials and one final probe trial. On each learning trial, the path length and time to reach the target are recorded. On each probe trial, the percent time spent in the spatial quadrant where the target is located is recorded. The dependent variable is a total composite score consisting of mean z-scores for path length, time to reach the target, and %time in the target quadrant during the probe trial (Total Composite). A change score is computed by subtracting the baseline Total Composite z-score from the post-intervention Composite z scores. Higher scores mean better outcome.
Time frame: Baseline and Post-Intervention (2 weeks)
Gait Stride Length Variability
Gait is assessed using the Primary Gait Screen (Schmidt et al., 2019) that requires participants to walk the length of an 8-meter pressure sensitive mat (Zeno Walkway, 120Hz, Zeno Metrics), turn around, and return to the beginning of the walkway. Gait variability during forward walking was selected because in PD, greater variability is associated with increased number of falls and is one of the most disabling symptoms in PD. For this outcome, variability in stride length is indexed by the individual's standard deviation (SD) of stride length measured in centimeters; higher SD scores indicate worse performance. A change score is calculated by subtracting baseline SD of stride length from the post-intervention scores. Negative change scores mean better performance, whereas positive change scores mean worse performance.
Time frame: Baseline and Post-Intervention (2 weeks)
Working Memory Composite From the NIH Examiner (Kramer et al., 2014)
This Working Memory composite is derived from a computer-based battery of executive functioning tasks (NIH Examiner). This composite was chosen due to known working memory difficulties in individuals with Parkinson disease. The Working Memory composite consists of scores from the N-back task and a Dot Counting task, which are combined to yield a composite score that ranges from -3 to 3.0; higher scores correspond to better working memory. A change score is calculated by subtracting the baseline Working Memory Composite from the post-intervention Working Memory Composite.
Time frame: Baseline and Post (2 weeks)
Rey Auditory Verbal Learning Test (RAVLT)
The RAVLT is a commonly used memory task in clinical settings. It is a 15-item word list learning task given over 5 trials followed by delayed recall of the list 20-30 minutes later. The major outcome is number of items freely recalled after the delay. Scores can range from 0 to 16 (maximum number of words), with higher score reflecting better performance. A change score is calculated by subtracting the baseline score from the post-intervention score. Higher difference scores indicate better performance due to intervention.
Time frame: Baseline and Post (2 weeks)
Negative Affect Scale From the Emotion Module of the NIH Toolbox
The Negative Affect scale is derived from the emotion module of the NIH Toolbox, a 12-22 minute self-report assessment that surveys current emotion health. The Negative Affect Scale is based on ratings of a series of emotion words. Questions comprise Likert-type items using computerized adaptive testing based on item response theory, resulting in a normed T score (mean of 50, SD of 10). The Negative Affect scale includes items pertaining to fear, anger, sadness. Scores below 40T indicate low levels of negative affect and scores above 60T indicate higher levels of negative affect. A difference score is computed by subtracting the baseline score from the post-intervention score.
Time frame: Baseline and Post-Intervention (2 weeks)
Unified Parkinson Disease Rating Scale Motor Scale (Part III) - Off Dopamine Medication
Part III of the Unified Parkinson Disease Rating Scale (UPDRS) is a standard clinical rating scale for motor symptoms in individuals with Parkinson disease. It is clinician administered by a trained rater and involves ratings of motor tremors, rigidity, and slowness. In the research setting, the scale is videotaped for later scoring by a trained rater who is blinded to group assignment. The Part III motor scale score ranges from 0 to 108 and involves 27 responses to 14 questions. Higher scores are worse and reflect more severe motor symptoms. A change score is computed by subtracting baseline UPDRS motor score from the post-intervention score. Greater change in negative direction reflects better outcome.
Time frame: Baseline and Post-Intervention
All Parkinson participants were recruited from the Fixel Institute of Neurological Disease at the University of Florida. Participants were recruited directly from clinics and/or from the INFORM database, an IRB approved database which includes individuals who agreed to be contacted by researchers for potential participation in ongoing IRB approved studies.
| Milestone | Active NIR-PBM Parkinson | Sham NIR-PBM Parkinson |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 7 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
The Fluency Composite is derived from the NIH Examiner, a computer-based battery of executive functioning tasks (Kramer et al., 2014). This composite was chosen due to known verbal fluency difficulties in individuals with Parkinson Disease. Verbal fluency tasks in the NIH Examiner include 2 trials of letter fluency and 2 trials of semantic fluency which are combined to yield a Fluency Composite that ranges from -3.0 to 3.0; higher scores correspond to better fluency performance. A change score is calculated by subtracting the baseline scores from the post-test scores. Greater positive change scores mean better outcome.
| z-score | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM |
|---|---|---|
| Fluency Composite From NIH Examiner (Kramer et al., 2014). | 0.334 ± 0.374 | -0.0287 ± 0.354 |
ARENA is a task of spatial memory-navigation that has been linked to hippocampal function and is a human analogue to the Morris water maze, which has shown sensitivity to NIR stimulation in Alzheimer's transgenic mice. ARENA requires participants to learn and navigate to a hidden target location in a simulated environment. It involves use of a joystick over a series of 8 learning trials and one final probe trial. On each learning trial, the path length and time to reach the target are recorded. The Learning dependent variable is a composite score consisting of mean z-scores for path length and for time to reach the target (Learning Composite). A change score is computed by subtracting the baseline Learning Composite from the post-intervention Learning Composite z-score. Higher scores mean a better outcome.
| z-score | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM |
|---|---|---|
| ARENA Spatial Navigation Memory Task-Learning Composite | -0.1088 ± 1.06 | -0.8495 ± 0.799 |
ARENA is a computer-based task of spatial memory-navigation that has been linked to hippocampal function and is a human analogue to the Morris water maze. ARENA consists of 9 learning trials and one final probe trial. On each learning trial, the path length and time to reach the target are recorded. On each probe trial, the percent time spent in the spatial quadrant where the target is located is recorded. The dependent variable is a total composite score consisting of mean z-scores for path length, time to reach the target, and %time in the target quadrant during the probe trial (Total Composite). A change score is computed by subtracting the baseline Total Composite z-score from the post-intervention Composite z scores. Higher scores mean better outcome.
| units on a scale | Parkinson Group- Active NIR-PBM | Parkinson Group - Sham NIR-PBM |
|---|---|---|
| ARENA Spatial Navigation Memory Task - Total Composite | -0.1750 ± .91776 | -0.4478 ± .5372 |
Gait is assessed using the Primary Gait Screen (Schmidt et al., 2019) that requires participants to walk the length of an 8-meter pressure sensitive mat (Zeno Walkway, 120Hz, Zeno Metrics), turn around, and return to the beginning of the walkway. Gait variability during forward walking was selected because in PD, greater variability is associated with increased number of falls and is one of the most disabling symptoms in PD. For this outcome, variability in stride length is indexed by the individual's standard deviation (SD) of stride length measured in centimeters; higher SD scores indicate worse performance. A change score is calculated by subtracting baseline SD of stride length from the post-intervention scores. Negative change scores mean better performance, whereas positive change scores mean worse performance.
| standard deviation | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM |
|---|---|---|
| Gait Stride Length Variability | -0.388 ± 1.097 | .854 ± 1.442 |
This Working Memory composite is derived from a computer-based battery of executive functioning tasks (NIH Examiner). This composite was chosen due to known working memory difficulties in individuals with Parkinson disease. The Working Memory composite consists of scores from the N-back task and a Dot Counting task, which are combined to yield a composite score that ranges from -3 to 3.0; higher scores correspond to better working memory. A change score is calculated by subtracting the baseline Working Memory Composite from the post-intervention Working Memory Composite.
| z-score | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM |
|---|---|---|
| Working Memory Composite From the NIH Examiner (Kramer et al., 2014) | 0.1491 ± 0.1516 | -0.1253 ± .4822 |
The RAVLT is a commonly used memory task in clinical settings. It is a 15-item word list learning task given over 5 trials followed by delayed recall of the list 20-30 minutes later. The major outcome is number of items freely recalled after the delay. Scores can range from 0 to 16 (maximum number of words), with higher score reflecting better performance. A change score is calculated by subtracting the baseline score from the post-intervention score. Higher difference scores indicate better performance due to intervention.
| score on a scale | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM |
|---|---|---|
| Rey Auditory Verbal Learning Test (RAVLT) | 2.38 ± 2.446 | 0.57 ± 1.272 |
The Negative Affect scale is derived from the emotion module of the NIH Toolbox, a 12-22 minute self-report assessment that surveys current emotion health. The Negative Affect Scale is based on ratings of a series of emotion words. Questions comprise Likert-type items using computerized adaptive testing based on item response theory, resulting in a normed T score (mean of 50, SD of 10). The Negative Affect scale includes items pertaining to fear, anger, sadness. Scores below 40T indicate low levels of negative affect and scores above 60T indicate higher levels of negative affect. A difference score is computed by subtracting the baseline score from the post-intervention score.
| T-score | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM |
|---|---|---|
| Negative Affect Scale From the Emotion Module of the NIH Toolbox | -1.95 ± 3.59 | -.922 ± 4.16 |
Part III of the Unified Parkinson Disease Rating Scale (UPDRS) is a standard clinical rating scale for motor symptoms in individuals with Parkinson disease. It is clinician administered by a trained rater and involves ratings of motor tremors, rigidity, and slowness. In the research setting, the scale is videotaped for later scoring by a trained rater who is blinded to group assignment. The Part III motor scale score ranges from 0 to 108 and involves 27 responses to 14 questions. Higher scores are worse and reflect more severe motor symptoms. A change score is computed by subtracting baseline UPDRS motor score from the post-intervention score. Greater change in negative direction reflects better outcome.
| score on a scale | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM |
|---|---|---|
| Unified Parkinson Disease Rating Scale Motor Scale (Part III) - Off Dopamine Medication | -3.87 ± 5.22 | 0.43 ± 7.91 |
Collected over 3 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parkinson Group NIR | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Parkinson Group - Sham | 0/8 (0%) | 1/8 (12.5%) | 0/8 (0%) |
| Event | Parkinson Group NIR | Parkinson Group - Sham |
|---|---|---|
| MedicationNervous system disorders | 0/8 | 1/8 |
| Age, Continuous(years) | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM | Total |
|---|---|---|---|
| Mean | 73 ± 5.53 | 68.8 ± 2.67 | 71.07 ± 4.78 |
| Sex: Female, Male(Participants) | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 5 | 3 | 8 |
| Ethnicity (NIH/OMB)(Participants) | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 7 | 7 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 8 | 7 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| MoCA(units on a scale) | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM | Total |
|---|---|---|---|
| Mean | 25.2 ± 4.17 | 27.4 ± 3.2 | 26.4 ± 3.75 |
| Duration of Parkinson symptoms(years) | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM | Total |
|---|---|---|---|
| Mean | 7.75 ± 6.39 | 5.29 ± 2.21 | 6.6 ± 4.91 |
| Parkinson Subtype- Tremor Predominant(Participants) | Parkinson Group - Active NIR-PBM | Parkinson Group - Sham NIR-PBM | Total |
|---|---|---|---|
| Tremor Predominant | 6 | 5 | 11 |
| Akinetic Rigid | 2 | 2 | 4 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified cognitive, mood, and motor data will be made available to other researchers upon request.
Supporting information: Study protocol, Sap, Icf, Analytic code
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