~100 spots leftby Dec 2025

Phototherapy for Parkinson's Disease

(LIGHT-PD Trial)

Recruiting in Palo Alto (17 mi)
RD
Overseen byRay Dorsey, MD
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?

Research shows that phototherapy, including light therapy, can improve both motor and non-motor symptoms in Parkinson's Disease patients. Studies have found that light therapy can enhance movement abilities and reduce issues like depression and sleep disturbances.12345

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

Research Team

RD

Ray Dorsey, MD

Principal Investigator

University of Rochester

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)
See 1 more

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
See 1 more

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

Who Is Running the Clinical Trial?

PhotoPharmics, Inc.

Lead Sponsor

Trials
3
Recruited
470+

University of Rochester

Collaborator

Trials
883
Recruited
555,000+
Kevin Koch profile image

Kevin Koch

University of Rochester

Chief Executive Officer since 2020

PhD in Organic Chemistry from the University of Rochester

Brian Druker profile image

Brian Druker

University of Rochester

Chief Medical Officer since 2015

MD from Harvard Medical School

Findings from Research

Photobiomodulation has shown promise in improving locomotive behavior and neuroprotection in animal models of Parkinson's disease, with early human studies indicating positive effects on non-motor symptoms.
The review suggests that combining direct intracranial light delivery with indirect extracranial stimulation could optimize therapeutic outcomes for Parkinson's disease, addressing the challenges of reaching deep brain regions affected by the disease.
Exploring the Use of Intracranial and Extracranial (Remote) Photobiomodulation Devices in Parkinson's Disease: A Comparison of Direct and Indirect Systemic Stimulations.Johnstone, DM., Hamilton, C., Gordon, LC., et al.[2021]
This clinical trial is investigating the safety and efficacy of a novel transcranial LED helmet device called 'PDNeuro' for treating symptoms of Parkinson's disease in 40 participants over 24 weeks, using a randomized placebo-controlled design.
The study aims to assess improvements in mobility, fine motor skills, and cognition, with results expected to inform future larger trials on the effectiveness of photobiomodulation therapy in Parkinson's disease.
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.McGee, C., Liebert, A., Herkes, G., et al.[2022]
In a controlled trial involving patients with Parkinson's disease who had previously used bright light therapy (BT) for 4 months to 5 years, those who continued with polychromatic light therapy showed significant improvements in motor and secondary symptoms, as measured by various scales including the MDSUPDRS and PDQ-39.
Patients who switched to red light or discontinued BT experienced deterioration in their symptoms, highlighting the efficacy of polychromatic light therapy in managing both primary and secondary symptoms of Parkinson's disease.
Polychromatic Light Exposure as a Therapeutic in the Treatment and Management of Parkinson's Disease: A Controlled Exploratory Trial.Willis, GL., Boda, J., Freelance, CB.[2020]

References

Exploring the Use of Intracranial and Extracranial (Remote) Photobiomodulation Devices in Parkinson's Disease: A Comparison of Direct and Indirect Systemic Stimulations. [2021]
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]
Polychromatic Light Exposure as a Therapeutic in the Treatment and Management of Parkinson's Disease: A Controlled Exploratory Trial. [2020]
A historical justification for and retrospective analysis of the systematic application of light therapy in Parkinson's disease. [2022]
Efficacy and Safety of Light Therapy as a Home Treatment for Motor and Non-Motor Symptoms of Parkinson Disease: A Meta-Analysis. [2022]
Making Locally Fabricated Phototherapy Devices Work Better. [2020]
Clinical applications of photodynamic therapy. [2007]
Photodynamic therapy systems and applications. [2005]
Role of immunomodulation in diseases responsive to phototherapy. [2019]
Clinical application of the mirror irradiation technique in photodynamic therapy for malignant glioma. [2021]