Efficacy Study of Light Therapy as an Adjunctive Treatment for Parkinson's Disease

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Light therapy, Circadian rhythm Read More

Inclusion Criteria:

• 1.Males and females, with Stage II - III, idiopathic Parkinson's disease, as assessed by Hoehn-Yahr Scale
• 2. On an optimized, stable dopamine replacement therapy for at least 1 month

Exclusion Criteria:

• 1. Participants younger than 45 years old
• 2. Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the prospective subject's Baseline Evaluation or during their involvement in this investigation
• 3. Subjects who are medically complicated, medically unstable and/or have other severe co-morbid disease states, as determined by the Investigator.
• 4. History of psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely
• 5. History or current diagnosis of major psychiatric disorder including Bipolar I Disorder that could interfere with accurate assessment and effective treatment
• 6. Have a Beck Depression Inventory-II (BDI-II) score of greater than or equal to 14
• 7. An anticipated need for a change in dopamine replacement therapy during the subject's involvement in the investigation
• 8. Patients on stable anti-depressant dose for less than 6 weeks
• 9. Less than one month since stopping an anti-depressant or psychoactive medication
• 10. History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria
• 11. Active suicidal or homicidal ideation or plan as determined by the Investigator or have a score of greater than or equal to 2 on the DBDI-II.
• 12. Previous use of light therapy treatment
• 13. Females of childbearing potential, i.e. capable of becoming pregnant
• 14. Night shift work within the past 6 months or planned during the investigation
• 15. Have planned travel of more than two weeks outside of two time zones from home during involvement in the Investigation
• 16. Planned travel outside of two time zones from home during the last two months of the Subject's involvement in the Investigation

• 17. Current use or use within the previous 1 month of photosensitizing or other medications that in the opinion of the investigator would interfere with the safety of the Subject during the trial including

  • amiodarone
  • benoxaprofen
  • chlorpromazine
  • demeclocycline
  • fleroxacin
  • nalidixic acid
  • ofloxacin
  • piroxicam
  • porfimer
  • psoralens
  • quinidine
  • temoporfin tetracycline
  • oral isoretinoin (Accutane)
  • St. John's wort
  • melatonin
• 18. Have a history of significant eye trauma or disease, retinopathy, and/or cataract of a level that would significantly affect transmission or processing of light through either eye
• 19. Other neurological disorders that in the opinion of the Investigator would interfere with the conduct of the study
• 20. Pre-existing major joint problems that in the opinion of the Investigator would interfere with the conduct of the study
• 21. History of cerebral insult or central nervous system infection that in the opinion of the Investigator would preclude successful participation in Investigation related procedures
• 22. Cognitive impairment, e.g. as determined by the Montreal Cognitive Assessment, that in the opinion of the Investigator would interfere with the conduct of the Investigation
• 23. Focal neurological deficits that in the opinion of the Investigator would interfere with the conduct of the Investigation
• 24. High dopamine replacement therapy (DART) dosage levels or severe dyskinesia attributable to DART that would preclude successful participation in the Investigation related procedures or interventions in the opinion of the site Investigator