Parkinson Disease, Transcranial Magnetic Stimulation
Conditions
Brief summary
The goal of this clinical trial is to learn about the efficacy of low-frequency rTMS of the cerebellum in Parkinson's disease.
Detailed description
The main question it aims to answer is: how to improve Parkinson's disease by rTMS. Participants will be treated with active low-frequency rTMS/sham rTMS over the cerebellum and receive: 1) resting state functional magnetic resonance imaging (fMRI), 2) blood sampling, and 3) Unified Parkinson Disease Rating Scale (UPDRS) before and after the treatment course. Researchers will compare the data collected from fMRI scan, blood sample analysis, and UPDRS rating between the active rTMS group and sham controls before and after the treatment to see if there are meliorating effects of rTMS on Parkinson's disease.
Interventions
DEVICEsham rTMS
The coil was held while disconnected from the stimulator, and rTMS noise was presented with computer loudspeakers with recorded sound from a real stimulation (20 minutes for each side of the lateral cerebellum everyday for 2 weeks).
DEVICEactive rTMS
Low-frequency (1 Hz) rTMS at with a stimulation intensity of 95% of the motor threshold will be delivered over the bilateral cerebellum for patients with Parkinson's disease (20 minutes for each side of the lateral cerebellum everyday for 2 weeks).
Sponsors
Nanjing University
Jiangsu Province Nanjing Brain Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with Parkinson's disease according to the clinical diagnostic criteria for Parkinson's disease (2015 edition) by the Movement Disorder Society (MDS) 2. Citizens of the People's Republic of China of either sex, aged between 40 and 80 years. 3. Able to give informed consent and follow the research plan. 4. Hoehn-Yahr (H-Y) stage ≤ 3 5. Patients received a Parkinson's stable medication before treatment (assessed via self report), which continued during treatment.
Exclusion criteria
1. History or diagnosis of severe psychiatric disorders, such as depression, anxiety disorders, schizophrenia spectrum disorders, and bipolar disorders. 2. Subjects with a clinically defined neurological disorder (assessed via self report) including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, history of stroke, transient ischemic attack within two years, cerebral aneurysm, dementia, multiple sclerosis. 3. Significant cognitive disorders (Mini-Mental State Exam (MMSE)\<24 points) or unable to complete the questionnaire independently. 4. Intracranial implants, such as cochlear implants, aneurysms clips, shunts, stimulators, electrodes, cardiac pacemakers and vagus nerve stimulation devices. 5. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold (assess via self report). 6. Showed significant discomfort after receiving the rTMS treatment. 7. Participated in other clinical trials. 8. Inability to read or understand Chinese.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Unified Parkinson's Disease Rating Scale (UPDRS) (version 3.0) score by rTMS treatment | Baseline, 2 weeks, and 3 months after rTMS treatment | UPDRS score will be collected from each participants to measure the severity and progression of Parkinson's disease with scores ranging from 0 (minimum) to 199 (maximum). The higher scores mean a worse outcome. |
| Changes of brain plasticity by rTMS treatment | Baseline, 2 weeks, and 3 months after rTMS treatment | Resting state fMRI will be scanned from each participants, and brain activity as well as fuctional connectivity will be analyzed. |
| Changes of circulating serum level of inflammatory cytokines (e.g., Interleukin-1beta (IL-1β), Interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-α)) by rTMS treatment | Baseline, 2 weeks, and 3 months after rTMS treatment | Blood samples will be collected from each participants, and serum levels of IL-1β, IL-6, and TNF-α will be measured by enzyme-linked immunosorbent assay (ELISA). |
Countries
China
Outcome results
None listed