Recruiting

Light Therapy

Sponsor:

University of Delaware

Code:

NCT06916260

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Red Light (PDT)

Placebo

Study Details

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 ID

NCT06916260

Start date

Apr 4, 2025

Status verified date

Feb, 2025

Completion date

Jul 30, 2026

Anticipated

Primary completion date

Jan 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Light therapy grpup

sham comparator: placebo light therapy

Interventions

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.

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.

Primary outcome measure

  • 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. ]
  • 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) ]

Central Contacts and Locations

Central contacts

Sara Penuela, PhD student

9739740120penuelas@udel.edu

Roxana Burciu, PhD, Associative Professor

rgburciu@udel.edu

Locations

University of Delaware STAR Tower

Recruiting

Newark, Delaware, United States, 19711

Contacts

Sara Penuela, PhD Student

973-974-0120penuelas@udel.edu

John Jeka, PdD

jjeka@udel.edu

Principal Investigator:

John Jeka, PhD

More Information

Sponsor

University of Delaware

Last update posted

Apr 8, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Delaware on 2025-04-08.