Development of non-invasive treatment for Parkinson's disease with violet light

JRCT ID: jRCTs032200104

Registered date:01/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Parkinson's disease
• Date of first enrollment: 01/09/2020
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Wearing violet light irradiation goggles

Outcome(s)

• Primary Outcome: Evaluation of safety by ophthalmic examination

Secondary Outcome

Evaluation of Parkinson's disease symptoms using various evaluation scales
Status of occurrence of adverse events and failures

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients diagnosed with Parkinson's disease according to MDS clinical diagnostic criteria for Parkinson's disease
2)Patients who have not changed or added any of the settings of levodopa preparation, dopamine agonist, antiparkinsonism drug, deep brain stimulator (DBS) within 4 weeks before obtaining consent
3)Patients with Modified Hoehn & Yahr severity of 4 degrees or less (4 degrees or less when off if there is a wear-off)
4)Patients with visual hallucinations (noise parade rear test 1 point or more)
5)It does not matter whether the patient is hospitalized or outpatient (outpatient preferred)
6)Patients who can assist wearing violet light irradiation goggles
7)Patients who can spend 3 hours in the daytime (11:00 to 14:00 as a guide) with the naked eyes when wearing violet light irradiation goggles
8)Men and women over the age of 20
9)Patients with written informed consent to participate in this study

Exclude criteria

1)Patients on continuous levodopa-carbidopa intestinal gel (LCIG) within 4 weeks before obtaining consent
2)Patients with epilepsy, severe heart, lung, kidney, liver or digestive disorders
3)Patients with severe cataract (nuclear sclerosis grade 3 or more)
4)Patient who performed ophthalmic surgery within 6 months before obtaining consent
5)Patients with retinal abnormalities such as serous retinal detachment and retinal hemorrhage
6)Patients with a history of seizures or epilepsy
7)Patients with a history of cancer or patients with serious diseases such as cancer
8)Patients who are pregnant or breastfeeding
9)Other patients who are judged to be unsuitable by the investigator

Related Information

• Primary Sponsor: Genko Oyama
• Source(s) of Monetary Support: Tsubota Laboratory, Inc.