Light Therapy in Parkinson's Disease

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Устройство 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. T

Первичные конечные точки

• Changes from baseline in total sleep time(TST) by polysomnography (PSG) at the end of each intervention period [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)]

Вторичные конечные точки (12)

• Changes from baseline in MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score at the end of each intervention period [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)]
• Changes from baseline in Epworth sleepiness scale (ESS) score at the end of each intervention period [Срок оценки: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)]
• Changes from baseline in Morningness-Eveningness Questionnaire (MEQ) score at the end of each intervention period [Срок оценки: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)]
• Changes from baseline in Hamilton Anxiety Scale(HAMA) score at the end of each intervention period [Срок оценки: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)]
• Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score at the end of each intervention period [Срок оценки: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)]
• Changes in Montreal Cognitive Assessment (MoCA) score at the end of each intervention period [Срок оценки: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)]
• Changes from baseline in Non-Motor Symptoms Questionnaire at the end of each intervention period [Срок оценки: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)]
• Changes from baseline in Parkinson's Disease Questionnaire (PDQ-39) at the end of each intervention period [Срок оценки: visit1(baseline),visit2(4th week),visit3(8th week),visit4(12th week)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Neurology, Second Affiliated Hospital of Soochow University — Сучжоу

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06129942 · JD-LK2020062-R02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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