Effect of rTMS of the Cerebellum on Parkinson's Disease

NCT05850598 | Completed

• 1 other identifier: PDTMS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

• Changes of Unified Parkinson's Disease Rating Scale (UPDRS) (version 3.0) score by 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

  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

  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

Study Arms (2)

sham stimulation targeting the cerebellum

SHAM COMPARATOR

Patients will be randomly allocated into this group, and they will receive sham stimulation.

Device: sham rTMS

real rTMS targeting the cerebellum

ACTIVE COMPARATOR

Patients will be randomly allocated into this group, and they will receive real stimulation.

Device: active rTMS

Interventions

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).

sham stimulation targeting the cerebellum

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).

real rTMS targeting the cerebellum

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead
• Nanjing University: collaborator

Study Sites (1)

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Yang Pan, M. D.

  Jiangsu Province Nanjing Brain Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director Physician

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 9, 2023
• Study Start: May 10, 2023
• Primary Completion: October 21, 2025
• Study Completion: November 21, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)