Parkinson Disease Clinical Trial
Official title:
Light Therapy in Parkinson's Disease: a Prospective, Observational Study
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Department of Neurology, Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital of Soochow University |
China,
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
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05415774 -
Combined Deep Brain Stimulation in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04691661 -
Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease
|
Phase 2 | |
Active, not recruiting |
NCT05754086 -
A Multidimensional Study on Articulation Deficits in Parkinsons Disease
|
||
Completed |
NCT04045925 -
Feasibility Study of the Taïso Practice in Parkinson's Disease
|
N/A | |
Recruiting |
NCT04194762 -
PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation
|
N/A | |
Completed |
NCT02705755 -
TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)
|
Phase 2 | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT05830253 -
Free-living Monitoring of Parkinson's Disease Using Smart Objects
|
||
Recruiting |
NCT03272230 -
Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System
|
N/A | |
Recruiting |
NCT06139965 -
Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
|
||
Completed |
NCT04580849 -
Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
|
N/A | |
Completed |
NCT03980418 -
Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam
|
N/A | |
Completed |
NCT04477161 -
Effect of Ketone Esters in Parkinson's Disease
|
N/A | |
Completed |
NCT04942392 -
Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic
|
N/A | |
Terminated |
NCT03446833 -
LFP Beta aDBS Feasibility Study
|
N/A | |
Completed |
NCT03497884 -
Individualized Precise Localization of rTMS on Primary Motor Area
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT04997642 -
Parkinson's Disease and Movement Disorders Clinical Database
|
||
Completed |
NCT04117737 -
A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson
|
N/A | |
Recruiting |
NCT03618901 -
Rock Steady Boxing vs. Sensory Attention Focused Exercise
|
N/A |