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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06688357
Enrollment
23
Registered
2024-11-14
Start date
2019-06-26
Completion date
2022-08-15
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Photobiomodulation, Near Infrared Light, Parkinson Disease, Neurostimulation

Brief 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.

Interventions

DEVICEActive 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.

DEVICESham 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.

Sponsors

Parkinson's Disease Foundation
CollaboratorOTHER
The Parkinson's Institute
CollaboratorOTHER
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The study is triple blinded. One of the co-investigators not involved in participant contact created a color-coded randomization schedule that mapped onto the active vs sham conditions. The randomization schedule was used to assign participants to one vs another color group. The devices were color coded. As such, the project coordinator, research assistants, and the PI were unaware of the participant's intervention status other than color assignment. All statistical analyses were done blindly using the color code for groups.

Intervention model description

randomized, sham controlled

Eligibility

Sex/Gender
ALL
Age
62 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gait Stride Length VariabilityBaseline and Post-Intervention (2 weeks)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.
Fluency Composite From NIH Examiner (Kramer et al., 2014).Baseline and Post-Intervention (2 weeks)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.
ARENA Spatial Navigation Memory Task-Learning CompositeBaseline and Post-Intervention (2 weeks)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.
ARENA Spatial Navigation Memory Task - Total CompositeBaseline and Post-Intervention (2 weeks)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.

Secondary

MeasureTime frameDescription
Working Memory Composite From the NIH Examiner (Kramer et al., 2014)Baseline and Post (2 weeks)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.
Rey Auditory Verbal Learning Test (RAVLT)Baseline and Post (2 weeks)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.
Negative Affect Scale From the Emotion Module of the NIH ToolboxBaseline and Post-Intervention (2 weeks)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.

Other

MeasureTime frameDescription
Unified Parkinson Disease Rating Scale Motor Scale (Part III) - Off Dopamine MedicationBaseline and Post-InterventionPart 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

Of the 23 consented participants, seven were excluded and not randomized. This included two individuals who declined to participate due to requirement that they undergo pre and post intervention testing when they were 'off' their normal dopamine medications. Another five were excluded due to low scores on a cognitive screener (MoCA), high scores on a mood measure, and confounding medical comorbidities (i.e., TBI, stroke).

Participants by arm

ArmCount
Parkinson Group - Active NIR-PBM
Parkinson participants randomized to the Active group underwent baseline testing, followed by 6 sessions of transcranial NIR-PBM over a 2-week period, and immediate followup testing. Outcome measures were obtained at baseline and followup. Each intervention session involved 40 minutes of active NIR stimulation across a total 12 intracranial sites. Stimulation was delivered via use of a MedX console system involving six superluminous LED clusters. The power density used was 500 milliwatts (mW) with a cumulative fluence (energy density) of 312 Joules/cm2 (26 J/cm2 applied at 12 sites).
8
Parkinson Group - Sham NIR-PBM
Parkinson participants randomized to the Sham group underwent identical procedures as those in the 'active' group. However, during the intervention phase, the near infrared deliver device (MedX console) was modified and did not deliver NIR light when turned on. The Sham condition involved 6 intervention sessions over a 2-week period. Each session consisted of 40 minutes of sham NIR stimulation using a modified MedX delivery system.
7
Total15

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event01

Baseline characteristics

CharacteristicParkinson Group - Sham NIR-PBMTotalParkinson Group - Active NIR-PBM
Age, Continuous68.8 years
STANDARD_DEVIATION 2.67
71.07 years
STANDARD_DEVIATION 4.78
73 years
STANDARD_DEVIATION 5.53
Duration of Parkinson symptoms5.29 years
STANDARD_DEVIATION 2.21
6.6 years
STANDARD_DEVIATION 4.91
7.75 years
STANDARD_DEVIATION 6.39
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants14 Participants7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
MoCA27.4 units on a scale
STANDARD_DEVIATION 3.2
26.4 units on a scale
STANDARD_DEVIATION 3.75
25.2 units on a scale
STANDARD_DEVIATION 4.17
Parkinson Subtype- Tremor Predominant
Akinetic Rigid
2 Participants4 Participants2 Participants
Parkinson Subtype- Tremor Predominant
Tremor Predominant
5 Participants11 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
7 Participants15 Participants8 Participants
Sex: Female, Male
Female
4 Participants7 Participants3 Participants
Sex: Female, Male
Male
3 Participants8 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 8
other
Total, other adverse events
0 / 80 / 8
serious
Total, serious adverse events
0 / 81 / 8

Outcome results

Primary

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)

Population: Participants included nondemented individuals with Parkinson disease who were randomized to active or sham intervention groups. During outcome testing, PD participants were evaluated off their normal dose of dopamine medication, following the standard overnight washout period.

ArmMeasureValue (MEAN)Dispersion
Parkinson Group - Active NIR-PBMARENA Spatial Navigation Memory Task-Learning Composite-0.1088 z-scoreStandard Deviation 1.06
Parkinson Group - Sham NIR-PBMARENA Spatial Navigation Memory Task-Learning Composite-0.8495 z-scoreStandard Deviation 0.799
Comparison: independent sample t-test; Cohen's d effect sizep-value: 0.159t-test, 2 sided
Primary

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)

Population: Participants included nondemented individuals with Parkinson disease who were randomized to active or sham intervention groups. During outcome testing, PD participants were off their normal dose of dopamine medication, following the standard overnight washout period.

ArmMeasureValue (MEAN)Dispersion
Parkinson Group - Active NIR-PBMARENA Spatial Navigation Memory Task - Total Composite-0.1750 units on a scaleStandard Deviation 0.91776
Parkinson Group - Sham NIR-PBMARENA Spatial Navigation Memory Task - Total Composite-0.4478 units on a scaleStandard Deviation 0.5372
Comparison: independent samples t-test, cohen's d effect sizep-value: 0.503t-test, 2 sided
Primary

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)

Population: Participants included nondemented individuals with Parkinson disease who were randomized to active or sham intervention groups. During outcome testing, PD participants were off their normal dose of dopamine medication, following the standard overnight washout period.

ArmMeasureValue (MEAN)Dispersion
Parkinson Group - Active NIR-PBMFluency Composite From NIH Examiner (Kramer et al., 2014).0.334 z-scoreStandard Deviation 0.374
Parkinson Group - Sham NIR-PBMFluency Composite From NIH Examiner (Kramer et al., 2014).-0.0287 z-scoreStandard Deviation 0.354
Comparison: Independent sample t-test conducted to examine difference in pre-post intervention change scores for the active vs sham intervention groups. Cohen's d was calculated to determine effect size.p-value: 0.077t-test, 2 sided
Primary

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)

Population: Participants included nondemented individuals with Parkinson disease who were randomized to active or sham intervention groups. During outcome testing, PD participants were off their normal dose of dopamine medication, following the standard overnight washout period.

ArmMeasureValue (MEAN)Dispersion
Parkinson Group - Active NIR-PBMGait Stride Length Variability-0.388 standard deviationStandard Deviation 1.097
Parkinson Group - Sham NIR-PBMGait Stride Length Variability.854 standard deviationStandard Deviation 1.442
Comparison: Independent sample t-test used to examine pre-post intervention change scores in active vs sham groups; Cohen's d was calculated to estimate effect sizep-value: 0.08t-test, 2 sided
Secondary

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)

Population: Individuals with idiopathic Parkinson disease who were tested 'off' dopaminergic medications

ArmMeasureValue (MEAN)Dispersion
Parkinson Group - Active NIR-PBMNegative Affect Scale From the Emotion Module of the NIH Toolbox-1.95 T-scoreStandard Deviation 3.59
Parkinson Group - Sham NIR-PBMNegative Affect Scale From the Emotion Module of the NIH Toolbox-.922 T-scoreStandard Deviation 4.16
Comparison: independent sample t-tests examining Post-Baseline differences for the Active vs the Sham groups; Effect size computed using Cohen's d scorep-value: 0.614t-test, 2 sided
Secondary

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)

Population: Participants included nondemented individuals with Parkinson disease who were randomized to active or sham intervention groups. During outcome testing, PD participants were off their normal dose of dopamine medication, following the standard overnight washout period.

ArmMeasureValue (MEAN)Dispersion
Parkinson Group - Active NIR-PBMRey Auditory Verbal Learning Test (RAVLT)2.38 score on a scaleStandard Deviation 2.446
Parkinson Group - Sham NIR-PBMRey Auditory Verbal Learning Test (RAVLT)0.57 score on a scaleStandard Deviation 1.272
Comparison: independent sample t-test was used to examine difference in Post-Pre intervention change in the Active vs the Sham groups; Effect size was estimated using Cohen's d.p-value: 0.104t-test, 2 sided
Secondary

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)

Population: Participants included nondemented individuals with Parkinson disease who were randomized to active or sham intervention groups. During outcome testing, PD participants were off their normal dose of dopamine medication, following the standard overnight washout period.

ArmMeasureValue (MEAN)Dispersion
Parkinson Group - Active NIR-PBMWorking Memory Composite From the NIH Examiner (Kramer et al., 2014)0.1491 z-scoreStandard Deviation 0.1516
Parkinson Group - Sham NIR-PBMWorking Memory Composite From the NIH Examiner (Kramer et al., 2014)-0.1253 z-scoreStandard Deviation 0.4822
Comparison: independent sample t-test, Cohen d effect sizep-value: 0.149t-test, 2 sided
Other Pre-specified

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

Population: Patients with Parkinson disease who were tested off dopamine medication following standard overnight washout.

ArmMeasureValue (MEAN)Dispersion
Parkinson Group - Active NIR-PBMUnified Parkinson Disease Rating Scale Motor Scale (Part III) - Off Dopamine Medication-3.87 score on a scaleStandard Deviation 5.22
Parkinson Group - Sham NIR-PBMUnified Parkinson Disease Rating Scale Motor Scale (Part III) - Off Dopamine Medication0.43 score on a scaleStandard Deviation 7.91
Comparison: independent samples t-test, effect size computation (cohen's d)p-value: 0.23t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026