Parkinson's Disease Advanced Parkinson's Disease
Conditions
Interventions
For patients with advanced Parkinson's disease, transcranial magnetic stimulation using a magnetic stimulator will be performed at ultra-low frequency and maximum intensity for 5 consecutive days.
Transcranial Magnetic Stimulation (TMS)
Sponsors
Hamada Masashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with Parkinson's disease (clinically established PD or clinically probable PD) according to the "MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015)" for 5 years or more. (2) Patients receiving sufficient treatment with anti-Parkinsonian drugs, but experiencing a lack of efficacy due to problems associated with long-term use (3) Patients with Hoehn-Yahr stage >= III during the ON period (4) Patients requiring hospitalization for treatment or clinical evaluation of Parkinson's disease (5) Patients aged >= 18 years at the time of informed consent (6) No restriction on gender (7) Patients (or their legal representatives) who have provided written informed consent of their own free will after receiving and fully understanding a detailed explanation of the study (8) Patients capable of outpatient visits according to the study schedule
Exclusion criteria
Exclusion criteria: (1) Patients with metal close to the stimulation site (2) Patients with an implanted cardiac pacemaker (3) Patients with metal not close to the stimulation site, intracranial titanium products, or magnetic dentures or implants (4) Patients with a history of epilepsy or seizures, or intracranial lesions at risk for seizures (5) Patients taking medications that lower the seizure threshold (6) Patients with abuse of or withdrawal from alcohol, caffeine, or stimulants (7) Patients with serious physical complications (poorly controlled cerebrovascular disease, heart disease, chronic respiratory disease, hypertension, diabetes, or malignant tumors) (8) Patients who are pregnant or may be pregnant (9) Patients whose Parkinson's disease medication has been changed within the last 4 weeks (10) Other patients judged inappropriate for study participation by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MDS-UPDRS part 3 score in the early morning OFF state on day 3 after the end of stimulation compared to the early morning OFF state on the first day of stimulation | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change in MDS-UPDRS part 3 score in the ON state at 3 days and 1 month after treatment compared to baseline (2) Change in Hoehn-Yahr stage in the ON state at 3 days and 1 month after treatment compared to baseline (3) Change in total MDS-UPDRS score in the ON state at 3 days and 1 month after treatment compared to baseline (4) Change in MDS-UPDRS part 1, 2, and 4 scores at 3 days and 1 month after treatment compared to baseline (5) Change in OFF time and ON time recorded in patient diaries at 3 days and 1 month after treatment compared to baseline (6) Change in PDQ-39 score at 3 days and 1 month after treatment compared to baseline (7) Change in MoCA-J, HDS-R, and MMSE scores at 3 days and 1 month after treatment compared to baseline | — |
Contacts
Public Contactkazuki Yamada
The University of Tokyo Hospital
Outcome results
None listed