Effect of rTMS of the Cerebellum on Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson Disease; Transcranial Magnetic Stimulation

• Registration Number: NCT05850598
• Lead Sponsor: Jiangsu Province Nanjing Brain Hospital

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.

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-05-06
• Study First Posted: 2023-05-09
• Study Start: 2023-05-10
• Status Verified: 2025-05
• Primary Completion: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

Nanjing Brain Hospital; 🇨🇳 Nanjing, Jiangsu, China