Light Therapy in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Light Therapy in Parkinson's Disease: a Prospective, Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129942
• Other study ID #: JD-LK-2020-062-01
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Second Affiliated Hospital of Soochow University
• Contact: Chun-Feng Liu, PhD
• Phone: +86 512 67783307
• Email: liuchunfeng[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Rhythm Disorders
• Parkinson Disease
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• 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 09:00-11:00 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 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 09:00-11:00 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.

Locations

Country	Name	City	State
China	Department of Neurology, Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & 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. Erratum In: Mov Disord. 2018 Dec;33(12):1992. — View Citation

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. — View Citation

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 sever — View Citation

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. — View Citation

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.sle — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in total sleep time(TST) by polysomnography (PSG) at 12 weeks	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)
Primary	Changes from baseline in sleep efficient by polysomnography (PSG) at 12 weeks	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)
Primary	Change from baseline in REM sleep without atonia by (RWA) polysomnography (PSG) at 12 weeks	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)
Primary	Change from baseline in sleep onset latency polysomnography (PSG) at 12 weeks	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)
Primary	Change from baseline in Periodic Limb Movement during Sleep(PLMS) by polysomnography (PSG) at 12 weeks	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)
Secondary	Changes from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) score at 12 weeks	Unified Parkinson's Disease Rating Scale (UPDRS) is an effective tool to evaluate the severity of motor symptoms in patients with Parkinson's disease (PD).Each item is simply given a 5- point score: 0 (Absent) to 4 (Marked in amplitude and present most of the time).The higher the UPDRS score is, the worse the symptoms are.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes form baseline in Hoehn-Yahr scale at 12 weeks	In H-Y scale, PD is divided into 5 stages according to the range and extent of motor symptoms. The higher the H-Y scale is, the worse the symptoms are.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes form baseline in PDSS score scale at 12 weeks	The Parkinson's Disease Sleep Scale(PDSS) assesses a wide spectrum of disease-specific sleep problems. The best cut-off score was 120.The higher the PDSS is, the better the sleep quality is.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes form baseline in Pittsburgh sleep quality index (PSQI) score at 12 weeks	The Pittsburgh sleep quality index (PSQI) is widely used to measure sleep quality. The best cut-off score was 7. The higher the PSQI score is, the worse the sleep quality is.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes from baseline in REM sleep behavior disorder questionnaire-Hong Kong (RBDQ-HK) score at 12 weeks	REM sleep behavior disorder questionnaire-Hong Kong (RBDQ-HK) is widely used to assess the severity of RBD. The higher RBD-HK score is, the worse the symptoms are. In East China, the best cut-off value for RBDQ-HK was located at 17 with a sensitivity of 85% and specificity of 81% (AUC = 0.892) .	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes from baseline in Epworth sleepiness scale (ESS) score at 12 weeks	The Epworth sleepiness scale (ESS) measures daytime sleepiness. The best cut-off score was 10.The higher the ESS score is, the worse the fatigue symptoms are.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes from baseline in Morningness-Eveningness Questionnaire (MEQ) score at 12 weeks	The Morningness-Eveningness Questionnaire (MEQ) is the most widely known questionnaire to assess circadian preference. Cut-off points were evaluated: a range of 14-52 for Evening types, 53-64 for neither types, and 65-86 for Morning types.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes from baseline in Hamilton Anxiety Scale(HAMA) score at 12 weeks	The Hamilton Anxiety Scale(HAMA) is a widely used interview scale to measure the severity of a patient's anxiety . The HAMA score can range from 0 to 56. The higher the HAMA score is, the worse the symptoms are. The best cut-off score was14.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score at 12 weeks	The Hamilton Depression Scale-24(HAMD-24) is a test measuring the severity of depressive symptoms in individuals. The HAMA score can range from 0 to 56. The higher the HAMA score is, the worse the symptoms are.An optimal HAMD-24 cut-off score for distinguishing between patients with and without a depressive disorders was found to be 9/10,with a high area under the curve(AUC) (0.91) indicating excellent discrimination.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes in Montreal Cognitive Assessment (MoCA) score at 12 weeks	Montreal Cognitive Assessment (MoCA) is widely used to assess cognitive dysfunction. The MoCA score can range from 0 to 30.The best cut-off score was 26. The higher the HAMA score is, the better the cognitive function is.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes from baseline in Non-Motor Symptoms Questionnaire at 12 weeks	Non-Motor Symptoms Questionnaire(NMSQ)contains 30 items and requires patients to answer "yes" and "no" according to their own situation in the last month. It is widely used in the assessment of PD patients' non motor symptoms.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes from baseline in Parkinson's Disease Questionnaire (PDQ-39) at 12 weeks	The Parkinson's Disease Questionnaire (PDQ-39) is the most frequently used disease-specific health status measure.PDQ-39 total score equal or above 47 was the optimal cut-off associated with a high caregiver strain with a sensitivity of 83% and a specificity of 64% .	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes from baseline in Fatigue Severity Scale (FSS) at 12 weeks	The Fatigue Severity Scale (FSS) is a scale used in the evaluation of fatigue that affects patients. A list of 9 statements is provided. The best cut-off score was 4.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes from baseline in electroencephalogram(EEG) at 12 weeks	Amplitudes of various frequency bands in each cortical region of EEG reflects change of cortical activity.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes from baseline in the rhythmic level of melatonin in serum and saliva at 12 weeks	We collected saliva of participants in sections for 24 hours (6:00, 9:00, 12:00, 15:00, 18:00, 19:00, 20:00, 21:00, 22:00, 23:00, ten time points in total) and serum(8:00,20:00)to detect the level of melatonin. This outcome reflects change of biological rhythm.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)
Secondary	Changes from baseline in the rhythmic level of cortisol in serum and saliva at 12 weeks	We collected saliva of participants in sections for 24 hours (6:00, 9:00, 12:00, 15:00, 18:00, 19:00, 20:00, 21:00, 22:00, 23:00, ten time points in total) and serum(8:00,20:00)to detect the level of cortisol. This outcome reflects change of biological rhythm.	visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)