Phototherapy for Parkinson's Disease
(LIGHT-PD Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: PhotoPharmics, Inc.
Must be taking: Dopaminergic medications
Disqualifiers: Atypical Parkinsonian syndrome, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This is a pivotal study to determine whether light therapy can improve non-motor and motor function in Parkinson's disease, on top of current best medical treatment.
Will I have to stop taking my current medications?
The trial requires that you stay on your current Parkinson's medications without changes for at least 28 days before starting the study and during your participation.
What data supports the effectiveness of the treatment Celeste Specialized Phototherapy Device for Parkinson's Disease?
How does phototherapy differ from other treatments for Parkinson's Disease?
Phototherapy for Parkinson's Disease is unique because it involves using light to potentially modulate the immune system and influence disease processes, unlike traditional treatments that often focus on medication to manage symptoms. This approach is based on the idea that light can have therapeutic effects, as seen in its use for skin conditions and certain cancers.678910
Eligibility Criteria
This trial is for people with Parkinson's Disease who respond to dopaminergic medication, have been on treatment for at least a year, and have relatively good eyesight (corrective lenses are okay). They must be stable on their current Parkinson's medications for at least 28 days before the study starts.Inclusion Criteria
My Parkinson's medication doses have been stable for the last 28 days.
I have been responding to dopamine medication for over a year.
Relatively good eyesight as attested to by participants (Corrective lenses of at least 20/60)
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Exclusion Criteria
I have been diagnosed with an unusual form of Parkinson's disease.
I have used light therapy for Parkinson's disease before.
Significant OFF state or bothersome dyskinesias that in the judgment of the rater, would interfere with participation in the study
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (virtual)
Treatment
Participants use the Celeste specialized phototherapy device each evening for 1 hour at home
26 weeks
3 visits (virtual) at baseline, week 13, and week 26
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Celeste Specialized Phototherapy Device (Light Therapy)
Trial OverviewThe trial is testing if a Celeste Specialized Phototherapy Device can improve both movement and non-movement symptoms in those with Parkinson’s Disease when used alongside their regular medications.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Investigational DeviceActive Control1 Intervention
The Celeste device resembles a large tablet. It has a protective cover that folds into a stand and is magnetically attached to the back of the device. It produces a low intensity of specific bandwidths of light believed to be responsible for circadian and alerting responses in humans. The overall emission produces a pleasing soft glow of light.
Group II: Control DevicePlacebo Group1 Intervention
The Control device is identical in appearance to Celeste. When turned on, the device emits a soft diffused light that is indistinguishable in color from the Active Device. However, this device produces a different amount of the specific wavelengths thought to be effective in the Active Device. It is impossible to tell the difference between the sham device and the active device by looking at them.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of RochesterRochester, NY
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Who Is Running the Clinical Trial?
PhotoPharmics, Inc.Lead Sponsor
University of RochesterCollaborator
References
Exploring the Use of Intracranial and Extracranial (Remote) Photobiomodulation Devices in Parkinson's Disease: A Comparison of Direct and Indirect Systemic Stimulations. [2021]In recent times, photobiomodulation has been shown to be beneficial in animal models of Parkinson's disease, improving locomotive behavior and being neuroprotective. Early observations in people with Parkinson's disease have been positive also, with improvements in the non-motor symptoms of the disease being evident most consistently. Although the precise mechanisms behind these improvements are not clear, two have been proposed: direct stimulation, where light reaches and acts directly on the distressed neurons, and remote stimulation, where light influences cells and/or molecules that provide systemic protection, thereby acting indirectly on distressed neurons. In relation to Parkinson's disease, given that the major zone of pathology lies deep in the brain and that light from an extracranial or external photobiomodulation device would not reach these vulnerable regions, stimulating the distressed neurons directly would require intracranial delivery of light using a device implanted close to the vulnerable regions. For indirect systemic stimulation, photobiomodulation could be applied to either the head and scalp, using a transcranial helmet, or to a more remote body part (e.g., abdomen, leg). In this review, we discuss the evidence for both the direct and indirect neuroprotective effects of photobiomodulation in Parkinson's disease and propose that both types of treatment modality, when working together using both intracranial and extracranial devices, provide the best therapeutic option.
Protocol for randomized controlled trial to evaluate the safety and feasibility of a novel helmet to deliver transcranial light emitting diodes photobiomodulation therapy to patients with Parkinson's disease. [2022]Parkinson's disease (PD) is the second most common, progressive, and debilitating neurodegenerative disease associated with aging and the most common movement disorder. Photobiomodulation (PBM), the use of non-thermal light for therapeutic purposes using laser or light emitting diodes (LED) is an emerging non-invasive treatment for a diverse range of neurological conditions. The main objectives of this clinical trial are to investigate the feasibility, safety, tolerability, and efficacy of a novel transcranial LED helmet device (the "PDNeuro") in the alleviation of symptoms of PD.
Polychromatic Light Exposure as a Therapeutic in the Treatment and Management of Parkinson's Disease: A Controlled Exploratory Trial. [2020]Parkinson's disease (PD) is a disorder characterized by loss of dopamine (DA) in the nigro-striatal dopamine (NSD) system with the primary symptoms of bradykinaesia, rigidity, tremor, and altered gate. Secondary symptoms including depression, insomnia, involuntary movement, and psychiatric side effects are also commonly observed. While the treatment focus for the past 50 years has been aimed at replacing deficient DA, to relieve the primary symptoms, more recent studies have suggested that the circadian system plays a critical role in the etiology and treatment of this disorder. Several case studies and open label trials have implemented bright light therapy (BT) in an attempt to repair sleep, depression and even the primary motor symptoms of this disorder, however controlled studies are yet to be fully implemented. In this controlled trial, patients that had been maintained on BT daily for 4 months to 5 years previously were assigned to one of three groups: continued polychromatic light, continued with red light or discontinued polychromatic light for a 2 week period. The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDSUPDRS), The Parkinson's Disease Questionnaire (PDQ-39), The Beck Depression Inventory II, The Beck Anxiety Inventory, The Epworth Sleep Scale (ESS) and a global rating scale were used to assess patients prior to and at 1 and 2 weeks after commencing the trial. Patients continuing polychromatic BT showed significant improvement on the MDSUPDRS Rating Scale (12 points; p = 0.028), the PDQ-39 (10 points; p = 0.011), ESS (4 points; p = 0.013), and numerous motor and secondary symptoms on a global rating scale. Performance on standardized motor tests also incrementally improved in this group while those exposed to red light and those that discontinued BT treatment deteriorated. These results demonstrate that strategically applied polychromatic light was beneficial in reducing many primary motor and secondary symptoms of PD. Further work investigating the role of light in mitigating PD symptoms and involvement of the circadian system will provide further advances in the treatment of PD. Clinical Trial Registration: http://www.anzctr.org.au, identifier ACTRN12617001309370.
A historical justification for and retrospective analysis of the systematic application of light therapy in Parkinson's disease. [2022]For the past 40 years the primary purpose of therapeutics for Parkinson's disease (PD) has been to replace deficient dopamine (DA) in the nigrostriatal dopamine (NSD) system. Even in the presence of limited efficacy, abundant side effects and impoverished quality of life, the involvement of other systems in the aetiology and treatment of this disorder has been sorely neglected and the excessive use of DA replacement therapy (DART) continues on a global basis. Recent scientific work suggests that the retina plays a major role in NSD function and intimates light therapy in the management of PD. After a thorough review of historical evidence supporting this contention, a retrospective, open-label study on 129 PD patients, whereby they were monitored for a period extending for a few months to eight years, was carried out. Primary motor and non-motor symptoms were monitored using an objectified global rating scale and timed motor tests that were assessed at regular intervals for the duration of the study. Thirty-one patients with other neurological disorders (OND) served as controls to determine whether any therapeutic effects seen with light were generalizable across other conditions. Patients were classified as compliant (COM), semi-compliant (SCOM), or early quit (EQUIT; prematurely discontinued treatment). EQUIT patients showed deterioration, while the COM group improved on most parameters. The SCOM patients were not as good as the COM group. The OND group showed significant improvement in depression and insomnia, but exposure to light did not improve motor function. The total drug burden of PD patients maintained on light was less with fewer side effects than SCOM or EQUIT groups. These results confirm the value of the strategic application of light therapy with controlled doses of DART in PD and warrants further controlled investigation. That the symptomatic improvement continued as long patients remained in the program suggests that exposure to light, under a strict daily regimen, combined with controlled DART, actively slows or arrests the progressive degenerative process underlying PD.
Efficacy and Safety of Light Therapy as a Home Treatment for Motor and Non-Motor Symptoms of Parkinson Disease: A Meta-Analysis. [2022]BACKGROUND Non-visual effects of the retina have been increasingly confirmed in developing Parkinson disease (PD). Light therapy (LT) has been proven to be an effective non-pharmacotherapy for improving the prognosis of PD, but the pathway of action is unclear, and there is a lack of a unified and standardized LT regimen. We aimed to evaluate the efficacy and safety of various LT measures in improving motor and non-motor symptoms in patients with idiopathic PD via a meta-analysis. MATERIAL AND METHODS CENTRAL, EMBASE, CINAHL, PEDro, and PubMed were searched for randomized controlled trials (RCTs) investigating the efficacy of LT for PD. Cochrane's Risk of bias tool and the GRADE approach were used to assess evidence quality. A meta-analysis and subgroup analyses evaluated the differences in efficacy produced by the different LT protocols. Trial sequential analysis (TSA) verified the analyses outcome and quantified the statistical relevance of the data.[color=#0e101a] [/color] RESULTS Patients receiving LT had significantly better scores for motor function (MD=-4.68, 95% Cl -8.25 to -1.12, P=0.01) compared with the control group exposed to dim-red light. In addition, in terms of non-motor symptoms, depression (SMD=-0.27, 95% Cl -0.52 to -0.02, P=0.04) and sleep disturbance-related scores (MD=3.45, 95% Cl 0.12 to 6.78, P=0.04) similarly showed significant optimization after receiving LT. CONCLUSIONS The results of this meta-analysis show strong evidence that LT has significant efficacy on motor and non-motor function in PD patients.
Making Locally Fabricated Phototherapy Devices Work Better. [2020]The efficiency of a phototherapy (PT) device is a function of the irradiance delivered by the device at the surface of the skin. Because cost limits the ability of health care facilities in low- and middle-income countries to procure commercial PT devices, efforts have gone into local fabrication of devices for use in health care facilities in Nigeria. Evaluation of such fabricated devices is yet to be conducted.
Clinical applications of photodynamic therapy. [2007]Photodynamic therapy is a modality for the treatment of malignant disease in which a photosensitive drug is selectively absorbed or retained by malignant tissues, after intravenous injection and is then photoactivated by light of an appropriate wavelength, often produced by a laser. Over the past two decades, the combination of haematoporphyrin derivative (HPD) and then its active component dihaematoprophyrin ether (DHE), now marketed as Photofrin, plus red light at 630 nm have been used in clinical practice for the treatment of a range of tumours; some very promising results have been obtained. Several countries have approved this drug/light combination for clinical use for a number of tumours. Some second generation photosensitising agents with appropriate light sources, and with perceived advantages over Photofrin, are under investigation, and it is to be hoped that major improvements in drug/light combinations will enable photodynamic therapy to achieve its full potential in the not-too-distant future.
Photodynamic therapy systems and applications. [2005]Photodynamic therapy (PDT) is a form of photochemotherapy requiring the simultaneous presence of a photosensitiser, activating light of the proper wavelength and molecular oxygen in order to produce a localised therapeutic effect thought to be due to high-energy singlet oxygen generation. Neither drug nor light alone are effective as therapeutic agents and thus PDT treatment methods should be looked upon as true, necessary, drug and device combinations ('systems'). Selectivity of treatment is imparted by a combination of factors, including accumulation of photosensitiser by the target lesion and targeted application of activating light. The most common systemic side effect of systemically administered photosensitisers is cutaneous photosensitivity of varying periods of time. Local toxicities depend on the area of treatment. Sources of light which have been used in PDT include lasers, arc lamps, light-emitting diodes and fluorescent lamps. PDT has been used for a wide variety of clinical applications. In 1995, the first PDT system, using porfimer sodium (Photofrin, Axcan Pharma, Inc.), lasers and fibre optic light delivery methods, developed by QuadraLogic Technologies, was approved in the US for endoscopic palliation of malignant dysphagia caused by oesophageal cancer. A topical PDT system, aminolevulinic acid HCL (Levulan Kerastick) and the large-area BLU-U PDT Illuminator, was developed by DUSA Pharmaceuticals, Inc. for the treatment of actinic keratoses of the face and scalp and approved in the US in 2000. Topical PDT has applicability to a wide variety of skin cancers and precancerous conditions. In 2001, Novartis launched the systemically administered verteporfin (Visudyne) laser-based PDT system in the US as the first pharmacologic treatment for age-related macular degeneration. Development programmes are continuing to investigate PDT for the potential treatment of a variety of diseases, yielding therapeutic results with minimal toxicity.
Role of immunomodulation in diseases responsive to phototherapy. [2019]Within the last two decades phototherapy has turned out to be a major therapeutic strategy in dermatology and thus has significantly influenced the treatment of many dermatoses. The goals of therapeutic photomedicine are the suppression of ongoing disease processes and, more importantly, the prevention, modulation, or abrogation of pathogenic mechanisms causing the disease. Therapeutic photomedicine has been largely empirical and most of it is still empirical today. However, parts of it are already based on the advances in photoimmunology and molecular biology. Although, we are far from a detailed understanding of the mechanisms underlying phototherapy, there is increasing evidence that phototherapy acts via modulation of the immune system. Most of the effects of both ambient and therapeutic ultraviolet radiation are immunosuppressive in nature.
Clinical application of the mirror irradiation technique in photodynamic therapy for malignant glioma. [2021]Intraoperative photodynamic therapy (PDT) using talaporfin sodium for malignant glioma is effective both in the experimental and in the clinical setting. Because the irradiation unit is fixed to the objective lens of the operating microscope, blind spots for irradiation exist. To overcome this problem, we developed a mirror reflecting system using a modified dental mirror.