Parkinson DiseaseNCT02175472
Efficacy Study of Light Therapy as an Adjunctive Treatment for Parkinson's Disease
A study testing Spectramax light therapy device in people with Parkinson Disease, run by PhotoPharmics, Inc. at 3 sites in 2 countries.
Trial summary
Light treatment was originally employed in Parkinson's disease (PD) to determine if it might be effective in treating co-existing symptoms of depression and insomnia. However, a preliminary double-blind study as well as other studies reported significant improvement in both motor and co-existing Parkinsonian symptoms. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Spectramax light therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2014to 23 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Males and females, with Stage II - III, idiopathic Parkinson's disease, as assessed by Hoehn-Yahr Scale
- 2. On an optimized, stable dopamine replacement therapy for at least 1 month
Who cannot join
- 1. Participants 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 prospective subject's Baseline Evaluation or during their involvement in this investigation
- 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 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. Have a Beck Depression Inventory-II (BDI-II) score of greater than or equal to 14
Show all 39Show fewer
- 7. An anticipated need for a change in dopamine replacement therapy during the subject's involvement in the investigation
- 8. Patients on stable anti-depressant dose for less than 6 weeks
- 9. Less than one month since stopping an anti-depressant or psychoactive medication
- 10. History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria
- 11. Active suicidal or homicidal ideation or plan as determined by the Investigator or have a score of greater than or equal to 2 on the DBDI-II.
- 12. Previous use of light therapy treatment
- 13. Females of childbearing potential, i.e. capable of becoming pregnant
- 14. Night shift work within the past 6 months or planned during the investigation
- 15. Have planned travel of more than two weeks outside of two time zones from home during involvement in the Investigation
- 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
- amiodarone
- benoxaprofen
- chlorpromazine
- demeclocycline
- fleroxacin
- nalidixic acid
- ofloxacin
- piroxicam
- porfimer
- psoralens
- quinidine
- temoporfin tetracycline
- oral isoretinoin (Accutane)
- St. John's wort
- melatonin
- 18. Have a 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 the conduct of the study
- 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 dopamine replacement therapy (DART) dosage levels or severe dyskinesia attributable to DART that would preclude successful participation in the Investigation related procedures or interventions in the opinion of the site Investigator
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
Aspen Clinical Research
Orem, Utah, 84058
About this study
Official title: Sixty Minute Exposure of Specific Bandwidth Light for the Treatment of Idiopathic Parkinson's Disease
Light treatment was originally employed in Parkinson's disease (PD) to determine if it might be effective in treating co-existing symptoms of depression and insomnia. However, a preliminary double-blind study as well as other studies reported significant improvement in both motor and co-existing Parkinsonian symptoms. As of yet, no long term double blind study has validated these findings. This study will use a double-blind design to evaluate the safety and efficacy of a non-invasive light therapy device to be used with ongoing pharmacotherapy for PD, over a six month treatment period.
Read the detailed description
Parkinson's disease (PD) is traditionally described as a disorder of compromised dopamine (DA) function in the nigro-striatal dopamine (NSD) system. This system extends from the midbrain, through the hypothalamus and into the forebrain to critical areas involved in the control of motor performance. Restoration of DA content in this system by administering the DA precursor L-dopa or DA agonists reinstates motor control, but provides only symptomatic relief with waning efficacy as the disease advances. Symptoms of depression and sleep disturbances are also commonly seen in PD patients, and the manifestation of these symptoms suggests impaired circadian function.
Although the involvement of the circadian system in PD was intimated in the first formal account of the disorder provided by James Parkinson, it was not until recently that circadian malfunction has been specifically cited as playing a major role in the development and progression of the disease. In addition to scattered reports depicting circadian-like features of PD and related syndromes, a large body of evidence describes the benefits of light therapy in PD from both the preclinical and clinical perspectives.
While the development of a formal understanding has been largely omitted as to the basis for any therapeutic effect exerted by light, recent studies have shown that the nigro-striatal dopamine system is comprised of the same cell type as cells in the retina and the pineal. Such cells are driven by visual input whereby dopamine and melatonin sit in functional opposition to regulate day night activities including sleep, mood, reproduction, anti-oxidation and movement. Hence one may conclude that the circadian system plays a major role in many aspects of PD.
Recent work in PD has also suggested that the efficacy of light therapy is mediated by melatonin and dopamine function in the retina. On this basis it would be reasonable to assume that intervention into the function of the circadian system with light therapy in PD patients might well serve to modify the course and consequences of the disease. The present study serves to extend this finding to the point of providing a practical, non-invasive method for helping patients.
- Conditions
- Parkinson Disease
- Being tested
- Spectramax light therapy device, Control light device
- Keywords
- Parkinson's disease, Light therapy, Circadian rhythm
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectramax light therapy deviceDevice
Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.
Control light deviceDevice
The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.
| Study group | Role | What they receive |
|---|---|---|
| Spectramax light therapy device | Active comparator | Light therapy device which emits a specific bandwidth combination and intensity of light. Receives: Device: Spectramax light therapy device |
| Control light device | Sham comparator | Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response. Receives: Device: Control light device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Combined Scores (Sum) of Parts I, II, and III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (M (MDS-UPDRS) From Baseline to Endpoint at 6 Months.
Part I: Non-motor impact of experiences of daily living. Part I has 13 questions,the first 6 are assessed by the examiner, and the remaining 7 are usually self assessed, but may include the patient's caregiver. Each question = 0-4, range= 0 - 65.
Part II: Motor Aspects of Experiences of Daily Living: This portion of the scale assesses the motor impact of PD on patients' experiences of daily living. There are 13 questions which are a component of the self-administered Patient Questionnaire.Each question = 0-4, range = 0-65.
Part III: Motor Examination: This portion of the scale assesses the motor signs of PD and is administered by the evaluator. There are 18 questions, however several questions have multiple parts which are also scored. Each question 0-4, Total range=0-132. Higher score=more severe
Measured: Six Months
Secondary outcomes (4)
Change in the Clinical Global Impression- Improvement Scale (CGI-I) From Baseline to Endpoint at 6 Months.
The Clinical Global Impression of Improvement is an assessment of the clinician's view of the patient's global functioning. Participants are ranked "O" at baseline. The CGI-I ranks 0 - 7, with "0" being much improved, "4" being neutral, and "7" being much worse.
Measured: Six months
Change in the Score of the Parkinson's Disease Questionnaire - 39 From Baseline to Endpoint at 6 Months
The 39 question Parkinson's Disease Questionnaire (PDQ-39) is a widely used patient reported rating scale in Parkinson's disease. Respondents affirm if they have experienced problems due to their disease using a five point scale from never (0 points) to always (4 points, or worse) in doing common activities. The PDQ-39 is comprised of 8 domains: mobility, emotion, activities of daily living, cognition, stigma, social support, communication, bodily discomfort. Total possible range of scores = 0 - 156
The questions are divided into eight measurement scales each comprising 3 to 10 questions. The scores for the questions in each scale are totaled and normalized to a scale of 0 - 100, that is equivalent to percent of maximum score. The scales are; Mobility (MOB): Q1-10; Activities of Daily Life (ADL): Q11-16; Emotional Well Being (EMO): Q17-22; Stigma (STI): Q23-26; Social Support (SOC): Q27-29; Cognitions (COG): Q30-33; Communication (COM) Q34-36; and Bodily Discomfort (BOD): Q37-39.
Measured: Six months
Change in the Score of the Parkinson's Disease Sleep Scale-Disturbed Sleep, From Baseline to Endpoint at 6 Months.
The Parkinson's Disease Sleep Scale 2 (PDSS-2) is designed to assess nocturnal disability in Parkinson's disease. The PDSS-2 is a 15 question analog scale that ranks answers from 0 - 4, with 4 being worse. In addition to an overall assessment of sleep disability three aspects of sleep problems can be obtained; disturbed sleep (total of questions 1-3, 8 and 14), PD-specific nocturnal motor symptoms (total of questions 4-6, 12 and 13), and PD-specific nocturnal symptoms (Total of questions 7, 9-11 and 15). We selected the "Disturbed Sleep" subscale as a key secondary outcome measure. This subscale has a total range of 0 - 16, with 16 being more severe.
Measured: Six months
Change in the Score of the Epworth Sleepiness Scale From Baseline to Endpoint at 6 Months.
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness to help in diagnosing sleep disorders. The ESS questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 (none) to 3 (worse) for eight different everyday situations. The total range is 0 - 24, with higher scores representing worse severity.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2016
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhotoPharmics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Adams, Study director, PhotoPharmics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175472
- Sponsor's protocol ID
- CT1301
- Status last verified
- Oct 2018
- First submitted
- 24 Jun 2014
- Last updated
- 23 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wyman BT, Adams D, Hendrix S, Groves J, Croft W, Ellison N, Olanow CW, Kieburtz K. A double-blind, controlled trial of circadian effective light therapy in patients with Parkinson's disease. Neurotherapeutics. 2025 Oct;22(6):e00728. doi: 10.1016/j.neurot.2025.e00728. Epub 2025 Sep 2.
PubMed 40903343
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sixty Minute Exposure of Specific Bandwidth Light for the Treatment of Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02175472
- Acronym / sponsor ID
- CT1301
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Light therapy, Circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- PhotoPharmics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Posted 23 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Light treatment was originally employed in Parkinson's disease (PD) to determine if it might be effective in treating co-existing symptoms of depression and insomnia. However, a preliminary double-blind study as well as other studies reported significant improvement in both motor and co-existing Parkinsonian symptoms. As of yet, no long term double blind study has validated these findings. This study will use a double-blind design to evaluate the safety and efficacy of a non-invasive light therapy device to be used with ongoing pharmacotherapy for PD, over a six month treatment period.
Detailed description
Parkinson's disease (PD) is traditionally described as a disorder of compromised dopamine (DA) function in the nigro-striatal dopamine (NSD) system. This system extends from the midbrain, through the hypothalamus and into the forebrain to critical areas involved in the control of motor performance. Restoration of DA content in this system by administering the DA precursor L-dopa or DA agonists reinstates motor control, but provides only symptomatic relief with waning efficacy as the disease advances. Symptoms of depression and sleep disturbances are also commonly seen in PD patients, and the manifestation of these symptoms suggests impaired circadian function.
Although the involvement of the circadian system in PD was intimated in the first formal account of the disorder provided by James Parkinson, it was not until recently that circadian malfunction has been specifically cited as playing a major role in the development and progression of the disease. In addition to scattered reports depicting circadian-like features of PD and related syndromes, a large body of evidence describes the benefits of light therapy in PD from both the preclinical and clinical perspectives.
While the development of a formal understanding has been largely omitted as to the basis for any therapeutic effect exerted by light, recent studies have shown that the nigro-striatal dopamine system is comprised of the same cell type as cells in the retina and the pineal. Such cells are driven by visual input whereby dopamine and melatonin sit in functional opposition to regulate day night activities including sleep, mood, reproduction, anti-oxidation and movement. Hence one may conclude that the circadian system plays a major role in many aspects of PD.
Recent work in PD has also suggested that the efficacy of light therapy is mediated by melatonin and dopamine function in the retina. On this basis it would be reasonable to assume that intervention into the function of the circadian system with light therapy in PD patients might well serve to modify the course and consequences of the disease. The present study serves to extend this finding to the point of providing a practical, non-invasive method for helping patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spectramax light therapy device | Active comparator | Device: Spectramax light therapy deviceLight therapy device which emits a specific bandwidth combination and intensity of light. |
| Control light device | Sham comparator | Device: Control light deviceLight therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.Males and females, with Stage II - III, idiopathic Parkinson's disease, as assessed by Hoehn-Yahr Scale
- 2. On an optimized, stable dopamine replacement therapy for at least 1 month
Key exclusion criteria (39 listed)
- 1. Participants 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 prospective subject's Baseline Evaluation or during their involvement in this investigation
- 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectramax light therapy deviceSpectramax light therapy device emits a specific combination of bandwidths and intensities of light. | Device | Spectramax light therapy device |
| Control light deviceThe control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response. | Device | Control light device |
Primary outcome
Change in the Combined Scores (Sum) of Parts I, II, and III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (M (MDS-UPDRS) From Baseline to Endpoint at 6 Months.
Time frame: Six Months
Part I: Non-motor impact of experiences of daily living. Part I has 13 questions,the first 6 are assessed by the examiner, and the remaining 7 are usually self assessed, but may include the patient's caregiver. Each question = 0-4, range= 0 - 65. Part II: Motor Aspects of Experiences of Daily Living: This portion of the scale assesses the motor impact of PD on patients' experiences of daily living. There are 13 questions which are a component of the self-administered Patient Questionnaire.Each question = 0-4, range = 0-65. Part III: Motor Examination: This portion of the scale assesses the motor signs of PD and is administered by the evaluator. There are 18 questions, however several questions have multiple parts which are also scored. Each question 0-4, Total range=0-132. Higher score=more severe
4 secondary outcomes
Change in the Clinical Global Impression- Improvement Scale (CGI-I) From Baseline to Endpoint at 6 Months.
Time frame: Six months
Change in the Score of the Parkinson's Disease Questionnaire - 39 From Baseline to Endpoint at 6 Months
Time frame: Six months
Change in the Score of the Parkinson's Disease Sleep Scale-Disturbed Sleep, From Baseline to Endpoint at 6 Months.
Time frame: Six months
Change in the Score of the Epworth Sleepiness Scale From Baseline to Endpoint at 6 Months.
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40903343Wyman BT, Adams D, Hendrix S, Groves J, Croft W, Ellison N, Olanow CW, Kieburtz K. A double-blind, controlled trial of circadian effective light therapy in patients with Parkinson's disease. Neurotherapeutics. 2025 Oct;22(6):e00728. doi: 10.1016/j.neurot.2025.e00728. Epub 2025 Sep 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Adams study director
PhotoPharmics, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectramax light therapy device in people with Parkinson Disease, run by PhotoPharmics, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Combined Scores (Sum) of Parts I, II, and III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (M (MDS-UPDRS) From Baseline to Endpoint at 6 Months. (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02175472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.