JPRN-jRCTs032200104
Active, not recruiting
未知
Development of non-invasive treatment for Parkinson's disease with violet light
Genko Oyama0 sites20 target enrollmentSeptember 1, 2020
ConditionsParkinson's disease
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Parkinson's disease
- Sponsor
- Genko Oyama
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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
Outcomes
Primary Outcomes
Not specified
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