None listed
Conditions
Brief summary
This study evaluated the efficacy of specific bandwidth phototherapy as an adjunctive treatment for the treatment of Parkinson’s disease. This study examined a non-invasive non-significant risk device to be used in combination with ongoing pharmacotherapy for Parkinson’s disease, in Parkinson’s patients already undergoing light therapy using broad spectrum, polychromatic light. While light treatment has been found to be effective in treating various forms of Parkinsonian symptoms it was originally employed to determine if it might be effective in treating comorbid symptoms of depression and insomnia associated with Parkinson’s disease. In several preclinical and clinical studies to date, not only has it been found that light therapy improves these parameters but the primary symptoms of bradykinaesia, rigidity, tremor and nocturnal myoclonus improved as well [Willis and Turner, Chronobiology International, 2007; Willis et al, Reviews in the Neurosciences, 2012; Rutten et al, Parkinson's Disorders, 2012; Videnovic et al, Movement. Disorders, 2017]. However, with continuing work on this theme the parameters surrounding the use of phototherapy have become better defined as to the frequency, time and duration of light use, the concomitant use of drugs and the management of physiological function so as to define the most effective treatment strategy for use in a double blind, placebo controlled trial. A preliminary blind trail has been undertaken which reports significant improvement in various Parkinsonian parameters (Paus et al, Movement. Disorders. 2007) and the present study implemented a more effective treatment regimen in a controlled design.
Interventions
The intervention employed in the SLIPD Study involved a modification of light therapy that had been employed in the clinic for a time ranging from 4 months to 5 years for patients attending the Bronowski Clinic. The fluorescent, polychromatic light source employed is an Apollo BL6 designed for the treatment of seasonal affective disorder (SAD). In patients already using the BL6 there were 3 groups employed in the study. the first is the active group that were supplied at the beginning of the t
The intervention employed in the SLIPD Study involved a modification of light therapy that had been employed in the clinic for a time ranging from 4 months to 5 years for patients attending the Bronowski Clinic. The fluorescent, polychromatic light source employed is an Apollo BL6 designed for the treatment of seasonal affective disorder (SAD). In patients already using the BL6 there were 3 groups employed in the study. the first is the active group that were supplied at the beginning of the trial with a slightly opaque, clear filter that only slightly decreased the total emission from the source by about 15% (otherwise the emission spectra remained the same, n=10). The second group received a filter that permitted the emission of only primary red (Lee Filters # 106) at the beginning of the study (n-10). The filters were fitted onto the light sources that had been in use by each patient prior to commencing the study. The light was situated approximately 1.0 metres from the patient which delivered approximately 3-4000 LUX of polychromatic light for 1 hour per night just prior to retiring. The procedure was the same as that occurring prior to the trial with the exception that a filter was applied after the first assessment on day 1 of the trial. To insure treatment compliance, the criterion of at least 4 months of program participation was chosen as such patients with such experience routinely exhibit long term commitment. In addition, patients are evaluated during each time point during the course of the trials in the presence of a carer, spouse, relative or partner to evaluate the level of compliance achieved. The trial lasted a total of 2 weeks with assessments made 1 and 2 weeks after commencing the trial.. Dr. Willis was the clinician instructing and monitoring and assessing the patients during the course of the trial. Dr. Willis has had more than 25 years experience in assessing PD patients and in the application of light treatment for neuropsychiatric disorders.
Sponsors
The Bronowski Institute of Behavioural Neuroscience Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A. Inclusion in the Bronowski Clinic Program for at least 4 months B. Idiopathic Parkinson's disease C. Receiving dopamine (DA) Replacement for at least 12 months
Exclusion criteria
1. Less than 12 months of responsive dopamine replacement therapy 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. History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by DSM-IV criteria 7. Active suicidal or homicidal ideation or plan, as determined by the attending clinician. 8. Use of light therapy treatment less than 4 months 9. Females of childbearing age 10. Currently working night shift 11. Planned travel outside of the state in which the trial is being conducted 12. Current use or use within the previous 1 month of photosensitizing or other medications including amiodarone, benoxaprofen, chlorpromazine, demeclocycline, fleroxacin, nalidixic acid, ofloxacin, piroxicam, porfimer, psoralens, quinidine, temoporfin tetracycline or oral isoretinoin (Accutane) or other remedies (St. John’s wort, melatonin) 13. 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 14. Other neurological disorders 15. Pre-existing major joint problems 16. Any history of cerebral insult or central nervous system infection 17. Cognitive impairment as determined by the attending clinician. 18. Focal neurological deficits 19. Severe dyskinaesia attributable to dopamine replacement therapy or high TDB.
Outcome results
None listed