Revitalize Cognition: Near Infrared Stimulation in Parkinson Patients

NCT06688357 | Completed Results FDA Device

• 3 other identifiers: IRB201400128-A6AZ15PF-IMP-1938
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Keywords

Photobiomodulation; Near Infrared Light; Parkinson Disease; Neurostimulation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline and Post-Intervention (2 weeks)

Secondary Outcomes (3)

• Working Memory Composite From the NIH Examiner (Kramer et al., 2014)

  Baseline and Post (2 weeks)

• Rey Auditory Verbal Learning Test (RAVLT)

  Baseline and Post (2 weeks)

• Negative Affect Scale From the Emotion Module of the NIH Toolbox

  Baseline and Post-Intervention (2 weeks)

Other Outcomes (1)

• Unified Parkinson Disease Rating Scale Motor Scale (Part III) - Off Dopamine Medication

  Baseline and Post-Intervention

Study Arms (2)

Active NIR-PBM Parkinson Group

ACTIVE COMPARATOR

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)

Sham NIR-PBM Parkinson Group

SHAM COMPARATOR

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)

Interventions

Active NIR-PBM (MedX 1116, MCT502) DEVICE

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

Active NIR-PBM Parkinson Group

Sham NIR-PBM (MedX 1116, MCT502) DEVICE

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

Sham NIR-PBM Parkinson Group

Eligibility Criteria

• Age: 62 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• th 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

Sponsors & Collaborators

• University of Florida: lead
• Parkinson's Disease Foundation: collaborator
• The Parkinson's Institute: collaborator

Study Sites (1)

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Limitations and Caveats

This trial was designed to assess feasibility and determine effect sizes for larger trial. Moving forward, the ARENA task is not an ideal memory measure in the PD cohort due to reliance on motor skills (i.e., using a joystick); this caveat is further amplified given that outcome testing took place when PD participants were "off" dopamine medications and thus experiencing more severe motor symptoms. This trial took place during COVID epidemic and resulted in smaller than hoped for sample.

Results Point of Contact

• Title: Dawn Bowers, Ph.D.
• Organization: University of Florida - Norman Fixel Brain Institute

dawnbowers@phhp.ufl.edu

(352) 273-6617

Study Officials

• Dawn Bowers, PhD

  The University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, sham controlled

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: June 26, 2019
• Primary Completion: February 17, 2021
• Study Completion: August 15, 2022
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available starting June 2026.
• Access Criteria: Requesters must have IRB approval.

Locations

US (1)