Efficacy Study of Light Therapy as an Adjunctive Treatment for Parkinson's Disease

NCT02175472 | Completed Results

• 1 other identifier: CT1301
• Study Type: interventional
• Target: 92
• Locations: 2 countries
• Sites: 3

Brief 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. 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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Light therapy; Circadian rhythm

Outcome Measures

Primary Outcomes (1)

• 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

  Six Months

Secondary Outcomes (4)

• Change in the Clinical Global Impression- Improvement Scale (CGI-I) From Baseline to Endpoint at 6 Months.

  Six months

• Change in the Score of the Parkinson's Disease Questionnaire - 39 From Baseline to Endpoint at 6 Months

  Six months

• Change in the Score of the Parkinson's Disease Sleep Scale-Disturbed Sleep, From Baseline to Endpoint at 6 Months.

  Six months

• Change in the Score of the Epworth Sleepiness Scale From Baseline to Endpoint at 6 Months.

  Six months

Study Arms (2)

Spectramax light therapy device

ACTIVE COMPARATOR

Light therapy device which emits a specific bandwidth combination and intensity of light.

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.

Device: Control light device

Interventions

Spectramax light therapy device DEVICE

Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.

Spectramax light therapy device

Control light device DEVICE

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.

Control light device

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, with Stage II - III, idiopathic Parkinson's disease, as assessed by Hoehn-Yahr Scale
• \. On an optimized, stable dopamine replacement therapy for at least 1 month

You may not qualify if:

• \. Participants younger than 45 years old
• \. 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
• \. Subjects who are medically complicated, medically unstable and/or have other severe co-morbid disease states, as determined by the Investigator.
• \. History of psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely
• \. History or current diagnosis of major psychiatric disorder including Bipolar I Disorder that could interfere with accurate assessment and effective treatment
• \. Have a Beck Depression Inventory-II (BDI-II) score of greater than or equal to 14
• \. An anticipated need for a change in dopamine replacement therapy during the subject's involvement in the investigation
• \. Patients on stable anti-depressant dose for less than 6 weeks
• \. Less than one month since stopping an anti-depressant or psychoactive medication
• \. 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
• \. 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.
• \. Previous use of light therapy treatment
• \. Females of childbearing potential, i.e. capable of becoming pregnant
• \. Night shift work within the past 6 months or planned during the investigation
• \. Have planned travel of more than two weeks outside of two time zones from home during involvement in the Investigation

Sponsors & Collaborators

• PhotoPharmics, Inc.: lead

Study Sites (3)

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

Location

Aspen Clinical Research

Orem, Utah, 84058, United States

Location

VU University Medical Center (VUmc)

Amsterdam, MB, 1007, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 40903343 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dan Adams
• Organization: PhotoPharmics, Inc.

dan.adams@photopharmics.com

801-770-6960

Study Officials

• Dan Adams

  PhotoPharmics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 23, 2016
• Last Updated: October 23, 2018
• Results First Posted: October 23, 2018

Record last verified: 2018-10

Locations

NL (1); US (2)