Revitalize Cognition: Near Infrared Stimulation in Parkinson Patients

NCT ID: NCT06688357

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2022-08-15

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active NIR-PBM Parkinson Group

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.

Group Type: ACTIVE_COMPARATOR

Active NIR-PBM (MedX 1116, MCT502)

Intervention Type: 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.

Sham NIR-PBM Parkinson Group

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).

Group Type: SHAM_COMPARATOR

Sham NIR-PBM (MedX 1116, MCT502)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Transcranial Near Infrared Stimulation; Photobiomodulation; Placebo

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

• Minimum Eligible Age: 62 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parkinson's Disease Foundation

OTHER

Sponsor Role: collaborator

The Parkinson's Institute

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn Bowers, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Florida

Locations

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

6AZ15

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PF-IMP-1938

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB201400128-A

Identifier Type: -

Identifier Source: org_study_id