Effect of rTMS of the Cerebellum on Parkinson's Disease
NCT ID: NCT05850598
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2023-05-10
2025-11-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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sham stimulation targeting the cerebellum
Patients will be randomly allocated into this group, and they will receive sham stimulation.
sham 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).
real rTMS targeting the cerebellum
Patients will be randomly allocated into this group, and they will receive real stimulation.
active 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).
Interventions
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sham 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).
active 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).
Eligibility Criteria
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Inclusion Criteria
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
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.
40 Years
80 Years
ALL
No
Sponsors
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Nanjing University
OTHER
Jiangsu Province Nanjing Brain Hospital
OTHER
Responsible Party
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Pan Yang
Assistant Director Physician
Principal Investigators
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Yang Pan, M. D.
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Province Nanjing Brain Hospital
Locations
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Nanjing Brain Hospital
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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PDTMS
Identifier Type: -
Identifier Source: org_study_id
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