Clinical trial NCT05850598: 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
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Transcranial Magnetic Stimulation
Lead sponsor: Jiangsu Province Nanjing Brain Hospital
Sponsor class: OTHER
Collaborators: name: Nanjing University
First posted: 2023-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of Unified Parkinson's Disease Rating Scale (UPDRS) (version 3.0) score by rTMS treatment
timeFrame: Baseline, 2 weeks, and 3 months after rTMS treatment
measure: Changes of brain plasticity by rTMS treatment
timeFrame: Baseline, 2 weeks, and 3 months after rTMS treatment
measure: 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
timeFrame: Baseline, 2 weeks, and 3 months after rTMS treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
Study officials:
affiliation: Jiangsu Province Nanjing Brain Hospital
name: Yang Pan, M. D.
role: PRINCIPAL_INVESTIGATOR
References: