Efficacy Study of Light Therapy as an Adjunctive Treatment for Parkinson's Disease
Completed · Not applicable
Conditions studied: Parkinson Disease
In brief
Light treatment was originally employed in Parkinson's disease (PD) to determine if it might be effective in treating co-existing symptoms of depression and insomnia. However, a preliminary double-blind study as well as other studies reported significant improvement in both motor and co-existing Parkinsonian symptoms. As of yet, no long term double blind study has validated these findings. This study will use a double-blind design to evaluate the safety and efficacy of a non-invasive light therapy device to be used with ongoing pharmacotherapy for PD, over a six month treatment period.
Key facts
- Study ID
- NCT02175472
- Run by
- PhotoPharmics, Inc.
- People needed
- 92
- Starts
- 2014-06-01
- Expected to finish
- 2016-12-23
- Last updated by the study team
- 2018-10-23
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States
- Aspen Clinical Research — Orem, Utah, United States
- VU University Medical Center (VUmc) — Amsterdam, MB, Netherlands
Full record on ClinicalTrials.gov
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