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Completed

NCT Number: NCT05850598

Effect of rTMS of the Cerebellum on Parkinson's Disease

The goal of this clinical trial is to learn about the efficacy of low-frequency rTMS of the cerebellum in Parkinson's disease.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies Transcranial Magnetic Stimulation

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with Parkinson's disease according to the clinical diagnostic criteria for Parkinson's disease (2015 edition) by the Movement Disorder Society (MDS)
  • Citizens of the People's Republic of China of either sex, aged between 40 and 80 years.
  • Able to give informed consent and follow the research plan.
  • Hoehn-Yahr (H-Y) stage ≤ 3
  • Patients received a Parkinson's stable medication before treatment (assessed via self report), which continued during treatment.

Exclusion criteria

  • History or diagnosis of severe psychiatric disorders, such as depression, anxiety disorders, schizophrenia spectrum disorders, and bipolar disorders.
  • 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.
  • Significant cognitive disorders (Mini-Mental State Exam (MMSE)<24 points) or unable to complete the questionnaire independently.
  • Intracranial implants, such as cochlear implants, aneurysms clips, shunts, stimulators, electrodes, cardiac pacemakers and vagus nerve stimulation devices.
  • 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).
  • Showed significant discomfort after receiving the rTMS treatment.
  • Participated in other clinical trials.
  • Inability to read or understand Chinese.

Treatment and study plan

sham rTMS

Device

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

Device

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).

Primary outcomes

  1. Changes of Unified Parkinson's Disease Rating Scale (UPDRS) (version 3.0) score by rTMS treatment

    Time frame: 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.

  2. Changes of brain plasticity by rTMS treatment

    Time frame: 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.

  3. 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Jiangsu Province Nanjing Brain Hospital

Other

Collaborators

  • Nanjing University

Registry information

Official study title

Effect of Low-frequency rTMS of the Cerebellum on Parkinson's Disease

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 9, 2023
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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