Light Therapy in Parkinson's Disease

NCT ID: NCT06129942

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2026-05-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

As the most important biologic rhythm timer, exogenous light supplement has certain benefits for the improvement of sleep quality and dementia. At present, it is gradually used in sleep and neuropsychiatric diseases. In an open study, 120 patients with PD received 4000 to 6000 lux of light, for 60 minutes before habitual bedtime. The patients were followed up for several months to 8 years, and it found the patients who persisted in the treatment improved their mood, anxiety and motor function. Clinical studies have confirmed the safety and effectiveness of light in improving insomnia and daytime sleepiness of PD patients. It was found that strong light can significantly improve the patients' motor and non-motor symptoms. However, these findings have not been reported in Chinese PD patients. The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease and explore the possible mechanism.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease Sleep Disorder Circadian Rhythm Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dim light group

treated with the placebo device which operates with one intensity of 300 lux \* 1 month

Group Type PLACEBO_COMPARATOR

Dim Light box

Intervention Type DEVICE

The light box uses a spectrally transparent prism diffuser, which can block ultraviolet rays, but will not affect the quality of the filtered light and will not turn yellow. The distance between the light box and the patient should not exceed 65cm.PD patients are selected for light intervention of different intensities. The control group is treated with 300 Lux intensity. The treatment time is 1 hour each day from 08:00-11:00 in the morning and 17:00-19:00 in the afternoon lasting for a month. The patient is asked to move under the light source, but should not fall asleep.

Bright light group

treated with the experimental device which operates with one intensity of 10,000 lux \* 1 month

Group Type EXPERIMENTAL

Bright light box

Intervention Type DEVICE

The light box uses a spectrally transparent prism diffuser, which can block ultraviolet rays, but will not affect the quality of the filtered light and will not turn yellow. The distance between the light box and the patient should not exceed 65cm.PD patients are selected for light intervention of different intensities. The experimental group is treated with 10,000 Lux intensity. The treatment time is 1 hour each day from 08:00-11:00 in the morning and 17:00-19:00 in the afternoon lasting for a month. The patient is asked to move under the light source, but should not fall asleep.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bright light box

The light box uses a spectrally transparent prism diffuser, which can block ultraviolet rays, but will not affect the quality of the filtered light and will not turn yellow. The distance between the light box and the patient should not exceed 65cm.PD patients are selected for light intervention of different intensities. The experimental group is treated with 10,000 Lux intensity. The treatment time is 1 hour each day from 08:00-11:00 in the morning and 17:00-19:00 in the afternoon lasting for a month. The patient is asked to move under the light source, but should not fall asleep.

Intervention Type DEVICE

Dim Light box

The light box uses a spectrally transparent prism diffuser, which can block ultraviolet rays, but will not affect the quality of the filtered light and will not turn yellow. The distance between the light box and the patient should not exceed 65cm.PD patients are selected for light intervention of different intensities. The control group is treated with 300 Lux intensity. The treatment time is 1 hour each day from 08:00-11:00 in the morning and 17:00-19:00 in the afternoon lasting for a month. The patient is asked to move under the light source, but should not fall asleep.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* According to the criteria of PD diagnosis of the MDS, PD patients were selected as the research object. The clinical symptoms of PD patients were consistent with Hoehn and Yahr stages 2-3.
* All PD patients have maintained stable drug treatment for at least one month, signed clinical informed consent and agreed not to adjust drugs throughout the light test and follow-up period.

Exclusion Criteria

* Using hypnotic or stimulating drugs.
* Using antidepressants, except stable drugs maintained for more than three months;
* Visual impairment, such as cataract, glaucoma, blindness, etc;
* Cognitive impairment (MMSE \< 24);
* There are uncontrollable hallucinations and mental diseases;
* There are sleep phase delay / advance syndrome, shift work, jet lag, etc
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chun-Feng Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chun-Feng Liu, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Soochow University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chun-Feng Liu, PhD

Role: CONTACT

+86 512 67783307

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chun-Feng Liu, Ph.D, M.D.

Role: primary

00 86 512 67783307

References

Explore related publications, articles, or registry entries linked to this study.

Fox SH, Katzenschlager R, Lim SY, Barton B, de Bie RMA, Seppi K, Coelho M, Sampaio C; Movement Disorder Society Evidence-Based Medicine Committee. International Parkinson and movement disorder society evidence-based medicine review: Update on treatments for the motor symptoms of Parkinson's disease. Mov Disord. 2018 Aug;33(8):1248-1266. doi: 10.1002/mds.27372. Epub 2018 Mar 23.

Reference Type BACKGROUND
PMID: 29570866 (View on PubMed)

Li Z, Tian T. Light Therapy Promoting Dopamine Release by Stimulating Retina in Parkinson Disease. JAMA Neurol. 2017 Oct 1;74(10):1267-1268. doi: 10.1001/jamaneurol.2017.1906. No abstract available.

Reference Type BACKGROUND
PMID: 28806435 (View on PubMed)

Rutten S, Vriend C, Smit JH, Berendse HW, Hoogendoorn AW, van den Heuvel OA, van der Werf YD. A double-blind randomized controlled trial to assess the effect of bright light therapy on depression in patients with Parkinson's disease. BMC Psychiatry. 2016 Oct 21;16(1):355. doi: 10.1186/s12888-016-1050-z.

Reference Type BACKGROUND
PMID: 27769202 (View on PubMed)

Paus S, Schmitz-Hubsch T, Wullner U, Vogel A, Klockgether T, Abele M. Bright light therapy in Parkinson's disease: a pilot study. Mov Disord. 2007 Jul 30;22(10):1495-1498. doi: 10.1002/mds.21542.

Reference Type BACKGROUND
PMID: 17516492 (View on PubMed)

Riemersma-van der Lek RF, Swaab DF, Twisk J, Hol EM, Hoogendijk WJ, Van Someren EJ. Effect of bright light and melatonin on cognitive and noncognitive function in elderly residents of group care facilities: a randomized controlled trial. JAMA. 2008 Jun 11;299(22):2642-55. doi: 10.1001/jama.299.22.2642.

Reference Type BACKGROUND
PMID: 18544724 (View on PubMed)

Rutten S, Vriend C, Smit JH, Berendse HW, van Someren EJW, Hoogendoorn AW, Twisk JWR, van der Werf YD, van den Heuvel OA. Bright light therapy for depression in Parkinson disease: A randomized controlled trial. Neurology. 2019 Mar 12;92(11):e1145-e1156. doi: 10.1212/WNL.0000000000007090. Epub 2019 Feb 15.

Reference Type BACKGROUND
PMID: 30770426 (View on PubMed)

Moges H, Vasconcelos OM, Campbell WW, Borke RC, McCoy JA, Kaczmarczyk L, Feng J, Anders JJ. Light therapy and supplementary Riboflavin in the SOD1 transgenic mouse model of familial amyotrophic lateral sclerosis (FALS). Lasers Surg Med. 2009 Jan;41(1):52-9. doi: 10.1002/lsm.20732.

Reference Type BACKGROUND
PMID: 19143012 (View on PubMed)

Videnovic A, Klerman EB, Wang W, Marconi A, Kuhta T, Zee PC. Timed Light Therapy for Sleep and Daytime Sleepiness Associated With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2017 Apr 1;74(4):411-418. doi: 10.1001/jamaneurol.2016.5192.

Reference Type BACKGROUND
PMID: 28241159 (View on PubMed)

Muntean ML, Benes H, Sixel-Doring F, Chaudhuri KR, Suzuki K, Hirata K, Zimmermann J, Trenkwalder C. Clinically relevant cut-off values for the Parkinson's Disease Sleep Scale-2 (PDSS-2): a validation study. Sleep Med. 2016 Aug;24:87-92. doi: 10.1016/j.sleep.2016.06.026. Epub 2016 Aug 24.

Reference Type RESULT
PMID: 27810191 (View on PubMed)

Opara J, Malecki A, Malecka E, Socha T. Motor assessment in Parkinson;s disease. Ann Agric Environ Med. 2017 Sep 21;24(3):411-415. doi: 10.5604/12321966.1232774. Epub 2017 May 11.

Reference Type RESULT
PMID: 28954481 (View on PubMed)

Shen SS, Shen Y, Xiong KP, Chen J, Mao CJ, Huang JY, Li J, Han F, Liu CF. Validation study of REM sleep behavior disorder questionnaire-Hong Kong (RBDQ-HK) in east China. Sleep Med. 2014 Aug;15(8):952-8. doi: 10.1016/j.sleep.2014.03.020. Epub 2014 May 14.

Reference Type RESULT
PMID: 24938584 (View on PubMed)

Torbey E, Pachana NA, Dissanayaka NN. Depression rating scales in Parkinson's disease: A critical review updating recent literature. J Affect Disord. 2015 Sep 15;184:216-24. doi: 10.1016/j.jad.2015.05.059. Epub 2015 Jun 10.

Reference Type RESULT
PMID: 26114228 (View on PubMed)

Oguh O, Kwasny M, Carter J, Stell B, Simuni T. Caregiver strain in Parkinson's disease: national Parkinson Foundation Quality Initiative study. Parkinsonism Relat Disord. 2013 Nov;19(11):975-9. doi: 10.1016/j.parkreldis.2013.06.015. Epub 2013 Jul 18.

Reference Type RESULT
PMID: 23871587 (View on PubMed)

Martinez-Martin P, Rodriguez-Blazquez C, Mario Alvarez, Arakaki T, Arillo VC, Chana P, Fernandez W, Garretto N, Martinez-Castrillo JC, Rodriguez-Violante M, Serrano-Duenas M, Ballesteros D, Rojo-Abuin JM, Chaudhuri KR, Merello M. Parkinson's disease severity levels and MDS-Unified Parkinson's Disease Rating Scale. Parkinsonism Relat Disord. 2015 Jan;21(1):50-4. doi: 10.1016/j.parkreldis.2014.10.026. Epub 2014 Nov 5.

Reference Type RESULT
PMID: 25466406 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

JD-LK2020062-R02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Photobiomodulation and Parkinson
NCT03811613 COMPLETED NA