angststoornissen Parkinson's disease / paralysis agitans
Conditions
Interventions
The Spectramax* light therapy device is an artificial light source with a
combined spectrum of blue/green light (460 * 570 nm) at an irradiance of
approximately 400 µW/cm2. The control light therapy
Sponsors
PhotoPharmics, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Males and females, with Stage II * IV, Idiopathic Parkinson*s Disease, as assessed by Hoehn-Yahr Scale 2. On optimized, stable dopamine replacement therapy for at least 1 month
Exclusion criteria
Exclusion criteria: 1. Subjects 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 start of the study or during the study 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 concurrent 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. Beck Depression Inventory score of greater than or equal to 14 7. Patients on stable anti-depressant dose for less than 6 weeks 8. An anticipated need for dopamine therapy change for the duration of the trial 9. Less than one month of stopping an anti-depressant or psychoactive medication 10. History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by DSM-5 criteria 11. Active suicidal or homicidal ideation or plan as determined by the Investigator, or a score of 2 or higher item 9 of the BDI-II. 12. Previous use of light therapy treatment 13. Females of childbearing age, e.i. capable of becoming pregnant 14. Night shift work within the past 6 months, or planned during the investigation 15. Planned travel for more than two weeks outside of two time zones from the state in which the trial is being conducted 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: a. amiodarone, b. benoxaprofen, c. chlorpromazine, d. demeclocycline, e. fleroxacin, f. nalidixic acid, g. ofloxacin, h. piroxicam, i. porfimer, j. psoralens, k. quinidine, l. temoporfin tetracycline, m. oral isoretinoin (Accutane), n. St. John*s wort, o. melatonin. 18. 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 subject compliance 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 Total Drug Burden or severe dyskinesia attributable to dopamine replacement therapy that would preclude successful participation in the Investigation related procedures or interventions in the opinion of the site Investigator. Total Drug Burden is defined as the total of the L-dopa equivalents, plus peripheral decarboxylase inh
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoint is the change in the MDS-UPDRS (Movement Disorders Society * Unified Parkinson*s Disease Rating Scale) composite score of sections II and III at Treatment Visit 3 (after six months of treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change of the scores on Parts I, II, III, IV and of the total MDS UPDRS. 2. Change of the score on the Beck Depression Inventory (BDI-II) 3. Change of the score on the Beck Anxiety Inventory (BAI) 4. Change of the three sub domain and total scores on the Parkinson*s Disease Sleep Scale-2 (PDSS 2) 5. Change of the score on the Epworth Sleepiness Scale (ESS) 6. Change of the eight sub-scales and total scores on the Parkinson's Disease Questionnaire (PDQ-39) 7. Change of the Clinical Global Impression - Severity Index (CGI-S), Efficacy Index (CGI-E) and final Global Improvement (CGI-I) score. 8. Change of the score on column 1, column 2 and combined total of the Wearing-Off Questionnaire (Q10) The following data will be collected and analyzed separately from the primary and secondary endpoint data for exploratory research purposes and will be reported separately from the Investigation Final Report: 9. Elbow-to-Fist (ETA) and Floor-to-Knee (FTK) Timed Motor Tests 10. Improvement of sleep latency, total sleep time, and number and frequency of awakenings as measured by actigraphy | — |
Countries
Netherlands
Outcome results
None listed