Effect of rTMS of the Cerebellum on Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05850598
• Other study ID #: PDTMS
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2024
• Source: Jiangsu Province Nanjing Brain Hospital
• Contact: Xiao-Yang Zhang, Ph.D.
• Phone: +8617712424530
• Email: xiaoyangzhang[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Transcranial Magnetic Stimulation

Intervention

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 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).

Locations

Country	Name	City	State
China	Nanjing Brain Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Province Nanjing Brain Hospital	Nanjing University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Changes of circulating serum level of inflammatory cytokines (e.g., Interleukin-1beta (IL-1ß), Interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-a)) by rTMS treatment	Blood samples will be collected from each participants, and serum levels of IL-1ß, IL-6, and TNF-a will be measured by enzyme-linked immunosorbent assay (ELISA).	Baseline, 2 weeks, and 3 months after rTMS treatment