Clinical trial NCT06916260: Light Therapy Intervention in Individuals With Parkinson's Disease
Official title: Light Therapy Intervention in Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: NeuroThera
First posted: 2025-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: There will be two groups that receive the light therapy and two that ill receive a placebo treatment to control for any possible effects of the therapy.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: cognitive symptom improvement
timeFrame: 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.
measure: motor symptoms
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware STAR Tower
state: Delaware
Study officials:
References: