Light Therapy Intervention in Individuals With Parkinson's Disease

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• cognitive symptom improvement [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

• Diagnosis of Parkinson disease

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Delaware STAR Tower — Newark

Идентификаторы

NCT: NCT06916260 · 2277769

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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