UMIN-CTR Clinical Trial

Public title

Clinical research of bright light therapy in Parkinson's disease / Parkinsonian syndrome

Acronym

Bright light therapy in Parkinson's disease

Scientific Title

Clinical research of bright light therapy in Parkinson's disease / Parkinsonian syndrome

Scientific Title:Acronym

Bright light therapy in Parkinson's disease

Region

Japan

Condition

Parkinson's disease and Parkinsonian syndrome

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Parkinson's disease has been described as a movement disorder with the dramatic effect of levodopa. However, there are reports that insomnia and depression tend to appear 10 years before the movement disorder, and such non-motor symptoms are noticed. On the other hand, as a result of excessive dopamine stimulation, it is difficult to treat due to side effects such as dyskinesia, wearing off phenomenon, visual hallucinations, and sleep attacks. Such excessive dopamine stimulation causes a phase advance of melatonin secretion, and an increase in daytime melatonin has been reported in patients exhibiting motor complication. Bright light therapy has been performed for depression, circadian rhythm abnormalities (jet lag) and the good results have been achieved. Improving circadian rhythm abnormalities in Parkinson's disease and treating depression, sleep abnormalities, etc. have been reported worldwide and have been somewhat successful. The purpose of this study is to introduce bright light therapy to Parkinson's disease and Parkinson's syndrome patients, and to investigate the improvement of non-motor symptoms and motor symptoms.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Unified Parkinson Disease Rating Scale(4 weeks, 8 weeks, 12 weeks of treatment start)

Key secondary outcomes

Sleep evaluation scale(4 weeks, 8 weeks, 12 weeks of treatment start)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

bright light therapy will be administered for 12 weeks, during which time the dosage of the antiparkinsonian drug will remain unchanged.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Patients themselves have agreed to participate in the exam, both in writing and by consent.
2. The age at the time of obtaining consent is 20 years or older and less than 85 years.
3.Patients with Parkinson's disease or Parkinson's syndrome with H & Y II or higher

Key exclusion criteria

1) Patients with ophthalmic disease
2) Patients with drug addiction / alcoholism
3) Patients with severe physical symptoms other than Parkinson's disease (heart, liver, renal dysfunction, hematopoietic disorders, etc.)
4) Patients with severe mental symptoms (confusion, hallucinations, delusions, abnormal behavior, etc.) within 3 months before obtaining consent form
5) Other patients who are judged inappropriate by the attending physician to participate in the study

Target sample size

20

Name of lead principal investigator

1st name	Takuyuki
Middle name
Last name	Endo

Organization

National Hospital Organization Osaka Toneyama Medical Center

Division name

Department of Neurology

Zip code

5608552

Address

5-1-1, Toneyama, Toyonaka, Osaka

TEL

+81-6-6853-2001

Email

endo.takuyuki.gr@mail.hosp.go.jp

Name of contact person

1st name	Takuyuki
Middle name
Last name	Endo

Organization

National Hospital Organization Osaka Toneyama Medical Center

Division name

Department of Neurology

Zip code

5608552

Address

5-1-1, Toneyama, Toyonaka, Osaka

TEL

+81-6-6853-2001

Homepage URL

Email

endo.takuyuki.gr@mail.hosp.go.jp

Institute

National Hospital Organization Osaka Toneyama Medical Center

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka Toneyama Medical Center Clinical Research Review Committee

Address

5-1-1, Toneyama, Toyonaka, Osaka

Tel

+81-6-6853-2001

Email

410-chiken@mail.hosp.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

02

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

20

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2013

Year

03

Month

15

Day

Date of IRB

2012

Year

02

Month

17

Day

Anticipated trial start date

2013

Year

03

Month

22

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

02

Month

27

Day

Last modified on

2020

Year

03

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045190