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Phototherapy for Parkinson's Disease (LIGHT-PD Trial)

N/A

Recruiting

Led By Ray Dorsey, MD

Research Sponsored by PhotoPharmics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable levodopa and other anti-PD medications for at least 28 days prior to screening

Diagnosis of Parkinson's disease as determined by the study PI, in keeping with the UK PD Society Brain Bank Criteria for the Diagnosis of PD

Must not have

Diagnosis of an atypical Parkinsonian syndrome

History of previous light therapy use for PD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Summary

This trial will help researchers understand if light therapy can improve movement and non-movement symptoms in Parkinson's disease, in addition to current medical treatment.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects of the phototherapy device may include eye strain or discomfort, headache, sleep disturbances or mood changes. However, specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Parkinson's medication doses have been stable for the last 28 days.

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I have been diagnosed with Parkinson's disease by a study leader.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with an unusual form of Parkinson's disease.

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I have used light therapy for Parkinson's disease before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Parkinson's Disease Questionnaire-39 (PDQ-39)

Secondary study objectives

Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2

Other study objectives

Beck Anxiety Scale (BAI)

Beck Depression Inventory -II (BDI-II)

Epworth Sleepiness Scale (ESS)

+8 more

Trial Design

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.

0 / 4Eligibility criteria met