Light Therapy Intervention in Individuals With Parkinson's Disease

NCT ID: NCT06916260

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-04
• Study Completion Date: 2026-07-30

Brief Summary

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Light therapy grpup

Group Type: ACTIVE_COMPARATOR

Red Light (PDT)

Intervention Type: 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 light therapy

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Placebo

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.

Intervention Type: DEVICE

Red Light (PDT)

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NeuroThera

INDUSTRY

Sponsor Role: collaborator

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Delaware STAR Tower

Newark, Delaware, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sara Penuela, PhD student

Role: CONTACT

penuelas@udel.edu

9739740120

Roxana Burciu, PhD, Associative Professor

Role: CONTACT

rgburciu@udel.edu

Facility Contacts

Sara Penuela, PhD Student

Role: primary

penuelas@udel.edu

973-974-0120

John Jeka, PdD

Role: backup

jjeka@udel.edu

Other Identifiers

2277769

Identifier Type: -

Identifier Source: org_study_id