Parkinson's disease
Conditions
Interventions
Intervention group:Intermittent theta burst stimulation
Sponsors
Fuzhou University Affiliated Provincial Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1)Diagnosed with primary Parkinson's disease (PD) according to the revised clinical diagnostic criteria of the International Movement Disorder Society (MDS, 2015 version) or the Chinese Parkinson's Disease Diagnostic Criteria (2016 version); (2)Aged between 40 and 80 years, with an age of diagnosis >=40 years; (3)2 <= Hoehn Yahr stage <= 4 (when the drug is "off"); (4)Stable use of anti-Parkinson’s disease medications for at least 1 month prior to enrollment and throughout the study; (5)Fully understand the trial and provide signed informed consent.
Exclusion criteria
Exclusion criteria: (1)Diagnosed with other neurological disorders such as stroke, brain tumor, traumatic brain injury, motor neuron disease, Alzheimer’s disease, or multiple sclerosis; (2)Implanted with metal medical devices such as deep brain stimulators, cardiac pacemakers, cochlear implants, or vagus nerve stimulators; (3)Presence of contraindications to MRI scanning, including claustrophobia, tattoos, or magnetic metal implants (to be confirmed with a specialist if necessary); (4)History of epilepsy or a first-degree relative with epilepsy; (5)Received other neuromodulation treatments (e.g., TMS, transcranial electrical stimulation, transcranial ultrasound stimulation) within 3 months prior to enrollment; (6)Suffering from severe organic diseases, such as malignant tumors, with a life expectancy of =24) or severe anxiety (HAMA >=29); (9)Diagnosed with other psychiatric disorders according to DSM-V criteria; (10)Evidence of alcohol abuse, drug abuse, or other substance abuse; (11)Other abnormalities identified during screening that, in the investigator’s judgment, make the patient unsuitable for participation; (12)Inability to complete follow-ups due to geographic or other reasons; (13)Women who are pregnant, breastfeeding, or planning/potentially becoming pregnant during the trial; (14)Currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MDS Unified-Parkinson Disease Rating Scale-III(MDS-UPDRS-?); | — |
Secondary
| Measure | Time frame |
|---|---|
| MDS Unified-Parkinson Disease Rating Scale-I,II,IV(MDS-UPDRS-?,?,?);Timed Up and Go Test (TUG);non-motor symptoms scale (NMSS);Hamilton Depression Scale-17 (HAMD-17);Hamilton Anxiety Scale (HAMA);Pittsburgh sleep quality index (PSQI);fatigue severity scale (FSS);Parkinson's Disease Quality of Life Questionnaire (PDQ-39); | — |
Countries
China
Contacts
Public ContactZhenhua Zhao
Fuzhou University Affiliated Provincial Hospital
Outcome results
None listed