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NCT Number: NCT06916260

Light Therapy Intervention in Individuals With Parkinson's Disease

The study looks to investigate the effects that light therapy delivered to the frontal cortex could have on Parkinson's disease related symptoms ( both cognitive and motor). The therapy is a non invasive technique that deliverers low level wavelength light to the front part of the head for 12 minutes. for this study the therapy will be done 3 times a week for 6 weeks. To measure the potential effects on the therapy in Parkinson symptoms, we will do a set of cognitive and motor test before and after the intervention to measure any changes as well as control for any potential markers such as age, sex, disease level, medication and exercise.

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Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware STAR Tower

Newark, Delaware, 19711, United States

Location status: Recruiting

Location contact

John Jeka, PdD

CONTACT

[email protected]

John Jeka, PhD

PRINCIPAL_INVESTIGATOR

Roxana Burciu, PhD

PRINCIPAL_INVESTIGATOR

Sara Penuela, PhD Student

CONTACT

[email protected]

973-974-0120

Thomas Buckley, PhED

PRINCIPAL_INVESTIGATOR

sara Penuela, PhD student

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Parkinson disease

Exclusion criteria

  • Participants who are unable to comply with study visit/testing requirements (e.g.

participants who cannot go off PD medication for the pre-, post-, and 3-month assessments).

  • Participants who are unable to provide consent.
  • Participants with a Deep Brain Stimulation (DBS) device.
  • Participants who have a history of a psychiatric disorder
  • Participants with PD who have other concurrent movement/neurological conditions, including dystonia, dementia, epilepsy etc.
  • Participants with a clinical diagnosis of PD that is not considered primary (e.g.

vascular parkinsonism) or participants where an atypical form of parkinsonism is suspected (e.g., progressive supranuclear palsy, multiple system atrophy).

  • Participants with a history of cancer (whether treated with chemotherapy and/or radiotherapy or not).
  • Participants with a history of a recent concussion or any facial, neck, or head injury within the last 6 months. UD IRB Approved: 03/12/2025 IRBNet ID#: 2277769-2 I/C from Rev. 01/2024 Page 3 of 10 Participant's Initial's ________
  • Known injury or disease that might interfere with motor function in the proposed experiments (e.g., stroke, traumatic brain injury, extrapyramidal dysfunction, neuromuscular disease, orthopedic problems that impair movement).
  • Participants with a history of photosensitivity.
  • Participants who are not able to walk unassisted for 2 minutes

Treatment and study plan

Red Light (PDT)

Device

The intervention is a non invasive and safe practice. By delivering low level wavelength red light to the front part of the head, it can increase blood flow in the area treated and improve functioning of the associated regions, potentially improving symptoms.

PLACEBO

Device

The intervention is a non invasive and safe practice. Participants will be wearing a helmet that delivered low level light therapy to the brain, and use it for the same amount of time as the treatment group. These participants will however, not receive the actual light and receive a placebo, so the helmet will be off. This is done to control of any potential positive effects of the therapy.

Primary outcomes

  1. cognitive symptom improvement

    Time frame: Done immediately before (pre test) and after (post test) intervention lasting about 1 hour. The intervention lasts about 6 weeks, so in between the pre and post tests there will be about a 6 week period.

    The investigators want to asses whether light therapy has a positive effect on reducing the cognitive symptoms related with PD, such as loss of short term memory, attention and processing speed. This will be measured using a set of tests and questioners (i.e MoCa, NIH cognitive battery, brief Test of attention (BTA)). Performance on these tests and questioners, which measure diverse aspects of cognition, will be compared before and after the intervention to establish if there is a positive effect of the therapy on any aspect of cognition. The intervention will last a total of 6 weeks right after the completion of the pre intervention assessment. after the completion of the 6 weeks of intervention therapy, the pre test will be conducted and cognitive measure changes will be recorded.

  2. motor symptoms

    Time frame: Done immediately before (pre test) and after(post test) intervention lasting about 1 hour. The intervention lasts 6 weeks, so there is about a 6 week period in between the two sessions ( pre and post)

    The investigators want to asses whether light therapy has a positive effect on reducing the motor symptoms related with PD, such as changes in gait, tremors, and slowing of movement. This will be measured using a set of tests and questioners (i.e MDSUPDRS, Dual task walking, APDM motion capture over a set of tests). Performance on these tests and questioners, which measure diverse aspects of motor capabilities, will be compared before (pre test) and after (post tests) the intervention to establish if there is a positive effect of the therapy on any aspect of motor control and movement. The intervention will last a total of 6 weeks, done right after the completion of the pre intervention assessment. after the completion of the 6 weeks of intervention therapy, the pre test will be conducted and any changes in motor measures will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Roxana Burciu, PhD, Associative Professor

CONTACT

[email protected]

Sara Penuela, PhD student

CONTACT

[email protected]

9739740120

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • NeuroThera

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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