An exploratory study to evaluate the eye movement in Parkinson disease

An open-label, unblinded, exploratory study to evaluate the eye movement in Parkinson disease patients - ExSEM-PD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044246

Enrollment

Registered

2021-05-18

Start date

2021-05-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Clinically established or probable Parkinson disease meeting the MDS clinical diagnosis criteria for Parkinson disease (2015) 2. Stage <= III on the Hoehn and Yahr scale in the ON state 3. Receiving treatment with L-DOPA for >= 6 months (26 weeks) and have been shown to be effective at the beginning of the administration 4. Advanced PD who will be hospitalized for medical evaluation, drug adjustment, and rehabilitation 5. Either hospitalized patient or outpatient 6. capable of giving a voluntary written informed consent after sufficient understanding of the research 7. Among those who use eyeglasses, those who can spend 6 hours corresponding to the evaluation time without using their own eyeglasses

Exclusion criteria

Exclusion criteria: 1. Atypical Parkinsonism syndromes 2. Dementia or at high risk of it (Mini Mental State Examination (MMSE) score < = 20) 3. Contraindicated for concomitant medications (L-DOPA / carbidopa) 4. Hypersensitivity to concomitant medications (L-DOPA / carbidopa) and/or their ingredients 5. Co-existing psychiatric disease (e.g., depression, bipolar disorder or schizophrenia) and/or clinically significant complications (e.g., cerebrovascular accident, heart disease, chronic respiratory disease, uncontrolled hypertension and diabetes) 6. History of psychiatric disease (e.g., depression, bipolar disorder or schizophrenia) and/or device-aided therapies (i.e., GPi pallidotomy, thalamotomy, and deep brain stimulation) 7. Those who are judged by the principal investigator to be inappropriate as research subjects

Design outcomes

Primary

Measure	Time frame
1. Clinical evaluation scales for Parkinson disease (Hoehn-Yahr, MDS-UPDRS, UDysRS, patient diary, PDQ-39, and EQ-5D-5L) 2. Eye movement (saccadic movement, eye blinks, eye blink speed, etc.) 3. Plasma levodopa concentration	—

Countries

Japan

Contacts

Public ContactNoriko Nishikawa

Juntendo University School of Medicine Department of Neurology

n.nishikawa.ts@juntendo.ac.jp03-3813-3111

Outcome results