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Effect of rTMS of the Cerebellum on Parkinson's Disease

Primary Purpose

Parkinson Disease, Transcranial Magnetic Stimulation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sham rTMS
active rTMS
Sponsored by
Jiangsu Province Nanjing Brain Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing Brain HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

sham stimulation targeting the cerebellum

real rTMS targeting the cerebellum

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
April 24, 2023
Last Updated
June 7, 2023
Sponsor
Jiangsu Province Nanjing Brain Hospital
Collaborators
Nanjing University
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1. Study Identification

Unique Protocol Identification Number
NCT05850598
Brief Title
Effect of rTMS of the Cerebellum on Parkinson's Disease
Official Title
Effect of Low-frequency rTMS of the Cerebellum on Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangsu Province Nanjing Brain Hospital
Collaborators
Nanjing University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sham stimulation targeting the cerebellum
Arm Type
Sham Comparator
Arm Description
Patients will be randomly allocated into this group, and they will receive sham stimulation.
Arm Title
real rTMS targeting the cerebellum
Arm Type
Active Comparator
Arm Description
Patients will be randomly allocated into this group, and they will receive real stimulation.
Intervention Type
Device
Intervention Name(s)
sham rTMS
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
active rTMS
Intervention Description
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 Outcome Measure Information:
Title
Changes of Unified Parkinson's Disease Rating Scale (UPDRS) (version 3.0) score by rTMS treatment
Description
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.
Time Frame
Baseline, 2 weeks, and 3 months after rTMS treatment
Title
Changes of brain plasticity by rTMS treatment
Description
Resting state fMRI will be scanned from each participants, and brain activity as well as fuctional connectivity will be analyzed.
Time Frame
Baseline, 2 weeks, and 3 months after rTMS treatment
Title
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
Description
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).
Time Frame
Baseline, 2 weeks, and 3 months after rTMS treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Yang Zhang, Ph.D.
Phone
+8617712424530
Email
xiaoyangzhang@nju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Pan, M. D.
Organizational Affiliation
Jiangsu Province Nanjing Brain Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Pan, M.D.
Phone
+8613952098253
Email
neuro_panyang@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of rTMS of the Cerebellum on Parkinson's Disease

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