Light Therapy Intervention in Individuals With Parkinson's Disease

University of Delaware

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: Placebo; Device: Red Light (PDT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06916260

2277769

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Parkinson disease

Exclusion criteria

1. 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).

2. Participants who are unable to provide consent.

3. Participants with a Deep Brain Stimulation (DBS) device.

4. Participants who have a history of a psychiatric disorder

5. Participants with PD who have other concurrent movement/neurological conditions, including dystonia, dementia, epilepsy etc.

6. 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).

7. Participants with a history of cancer (whether treated with chemotherapy and/or radiotherapy or not).

8. 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 ________

9. 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).

10. Participants with a history of photosensitivity.

11. Participants who are not able to walk unassisted for 2 minutes

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Light therapy grpup

Active Comparator group

Treatment:

Device: Red Light (PDT)

placebo light therapy

Sham Comparator group

Treatment:

Device: Placebo