Parkinson's disease Parkinson's disease
Conditions
Interventions
KMY-01 group: The KMY-01 will be used for 20 minutes twice a day (morning and afternoon) for 8 weeks at home.
Sham group: The patients will use the Sham machine for 20 minutes twice a day (morning and
D000069453
transcranial untrasonic stimulation
Sponsors
Yutaka Oji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Clinically established or probable Parkinson's disease diagnosed by MDS clinical diagnostic criteria (2) Written informed consent (3) Between 20 and 80 years of age at the time of consent (4) Outpatients or inpatients who are going to be discharged before Visit 2. (5) Patients who meet all of the following criteria prior to enrollment a. MDS-UPDRS Part III total score of 10 or more b. Hoehn&Yahr II or III c. Patients under standard pharmacotherapy for Parkinson's disease (6) Patients who are able to use the device and keep a subject diary by themselves or have a caregiver who is able to do so. (7) Patients who have been treated with certain dosage and administration of antiparkinsonian drugs (L-DOPA, dopamine agonist, MAOB inhibitor, etc.) for at least 4 weeks prior to the study and are taking L-DOPA regularly. (8) Patients who are judged by the principal investigator or subinvestigators to be adequately evaluated for the efficacy and safety of the study, taking into consideration the selection and exclusion criteria.
Exclusion criteria
Exclusion criteria: (1) Parkinsonism other than Parkinson's disease (2) Significant neurological or psychiatric disorders such as cerebrovascular disease, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, clinically evident cognitive dysfunction, head injury with loss of consciousness, history of brain surgery with residual deficits (3) Musculoskeletal disorders that interfere with the performance of the tests in this clinical trial. (4) Unable to be properly evaluated for MDS-UPDRS Part III. (5) Serious hepatic, renal, or cardiac complications (6) History of alcoholism or drug addiction (7) Medical electrical devices implanted in the body that are susceptible to electromagnetic interference, such as pacemakers, implantable cardioverter-defibrillators, and deep brain stimulations (8) Metal coils implanted in the skull (9) Hearing aids (cochlear implants, implantable hearing aids, etc.) that cannot be removed (removable hearing aids must be removed when using the KMY-01) (10) Pregnant or lactating female (11) Participated in previous KMY-01 clinical trials (12) Participated in other interventional studies or clinical trials within 6 months prior to obtaining consent (13) Patients who are judged to be inappropriate for the subject by the principal investigator or subinvestigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence rate of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change from baseline to week 4, week 8 and 12 in MDS-UPDRS Part I (Non-Motor Aspects of Experiences of Daily Living) 2) Change from baseline to week 4,week 8 and 12 in MDS-UPDRS Part II (Motor Aspects of Experiences of Daily Living) 3) Change from baseline to week 4,week 8 and 12 in MDS-UPDRS Part III (Motor Examination) 4) Change from baseline to week 4,week 8 and 12 in MDS-UPDRS Part IV (Motor Complications) 5) Change from baseline to week 4,week 8 and 12 in total score of MDS-UPDRS part I-IV 6) Change from baseline in MMSE and MoCA-J total scores at Weeks 4, 8, and 12 7) Change from baseline in patient-reported total daily hours in the ON and OFF states (symptom diary) at Weeks 4, 8, and 12 8) Change from baseline to week 4,week 8 and 12 in self-administered assessment items including PDSS-2 (sleep), RBDSQ (REM sleep behavior disorder), PDQ39 (quality of life), BDI-II (depression), PFS-16 (fatigue), KPPQ (pain), and SCOPA-AUT(functions of autonomic nervous system) 9) Incidence of device malfunction 10) Rescue medication or reduction of levodopa dose | — |
Contacts
Public ContactTakeshige-Amano Haruka
Juntendno Univerisity Hospital
Outcome results
None listed