Effect of rTMS of the Cerebellum on Parkinson's Disease

November 20, 2025 updated by: Pan Yang, Jiangsu Province Nanjing Brain Hospital

Effect of Low-frequency 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Nanjing Brain Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: sham stimulation targeting the cerebellum
Patients will be randomly allocated into this group, and they will receive sham stimulation.
Device: 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 Comparator: real rTMS targeting the cerebellum
Patients will be randomly allocated into this group, and they will receive real stimulation.
Device: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 2 weeks, and 3 months after rTMS treatment
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.
Baseline, 2 weeks, and 3 months after rTMS treatment
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).
Baseline, 2 weeks, and 3 months after rTMS treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Province Nanjing Brain Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nanjing University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yang Pan, M. D., Jiangsu Province Nanjing Brain Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PDTMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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