Light Therapy in Parkinson's Disease

NCT06129942 | Recruiting

• 1 other identifier: JD-LK2020062-R02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Sleep Disorder; Circadian Rhythm Disorders

Outcome Measures

Primary Outcomes (7)

• Changes from baseline in total sleep time(TST) by polysomnography (PSG) at the end of each intervention period

  Total sleep time is the sum of sleep time in each period. This outcome reflects change of patients' sleep quality.

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

• Changes from baseline in sleep efficient by polysomnography (PSG) at the end of each intervention period

  Sleep efficiency is the ratio of the total time spent asleep (total sleep time) in a night compared to the total amount of time spent in bed. This outcome reflects change of patients' sleep quality.

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

• Change from baseline in REM sleep without atonia by (RWA) polysomnography (PSG) at the end of each intervention period

  REM sleep without atonia (RWA) is the PSG finding of persistent muscle tone during REM sleep, resulting in paroxysmal phasic or tonic EMG activity. Together with dream-enacting behavior (DEB), RSWA is a necessary diagnostic criterion of REM sleep behavior disorder (RBD). This outcome reflects change of RBD severity.

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

• Change from baseline in sleep onset latency polysomnography (PSG) at the end of each intervention period

  Sleep latency is the amount of time it takes patients to go from being fully awake to sleeping. Patients' sleep latency and how quickly they reach rapid eye movement (REM) sleep can be indicators of the amount and quality of sleep they are getting.

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

• Change from baseline in Periodic Limb Movement during Sleep(PLMS) by polysomnography (PSG) at the end of each intervention period

  Periodic limb movement during sleep (PLMS) is is described as a stereotypical involuntary movement during sleep. In particular, presenting more than 15 periodic limb movements per hour is related to daytime sleepiness due to low sleep quality. This outcome reflects change of patients' sleep quality.

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

• Changes from baseline in duration and percentage of each sleep stage by polysomnography (PSG) at the end of each intervention period

  Changes in the length and percentage of N1, N2, N3 and REM sleep,which reflect changes in sleep structure.

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

• Changes from baseline in slow wave activity(SWA) and slow wave energy(SWE) by polysomnography (PSG) at the end of each intervention period

  SWA and SWE are indicators of sleep depth and homeostasis in PSG.

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

Secondary Outcomes (17)

• Changes from baseline in MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score at the end of each intervention period

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

• Changes form baseline in Hoehn-Yahr scale at the end of each intervention period

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

• Changes form baseline in PDSS-2 score scale at the end of each intervention period

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

• Changes form baseline in Pittsburgh sleep quality index (PSQI) score at the end of each intervention period

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

• Changes from baseline in REM sleep behavior disorder questionnaire-Hong Kong (RBDQ-HK) score at the end of each intervention period

  visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)

Study Arms (2)

Dim light group

PLACEBO COMPARATOR

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

Device: Dim Light box

Bright light group

EXPERIMENTAL

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

Device: Bright light box

Interventions

Bright light box 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.

Bright light group

Dim Light box 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.

Dim light group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

RECRUITING

Related Publications (14)

• 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.

  PMID: 29570866 BACKGROUND

• 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.

  PMID: 28806435 BACKGROUND

• 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.

  PMID: 27769202 BACKGROUND

• 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.

  PMID: 17516492 BACKGROUND

• 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.

  PMID: 18544724 BACKGROUND

• 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.

  PMID: 30770426 BACKGROUND

• 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.

  PMID: 19143012 BACKGROUND

• 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.

  PMID: 28241159 BACKGROUND

• 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.

  PMID: 27810191 RESULT

• 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.

  PMID: 28954481 RESULT

• 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.

  PMID: 24938584 RESULT

• 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.

  PMID: 26114228 RESULT

• 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.

  PMID: 23871587 RESULT

• 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.

  PMID: 25466406 RESULT

MeSH Terms

Conditions

Parkinson Disease; Sleep Wake Disorders; Chronobiology Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Chun-Feng Liu, PhD

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Feng Liu, PhD

CONTACT

+86 512 67783307; liuchunfeng@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: November 13, 2023
• Study Start: September 1, 2021
• Primary Completion (Estimated): May 16, 2026
• Study Completion (Estimated): May 16, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)