Using rTMS on the cerebellum to treat Parkinson's disease

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

This study is testing if a new brain treatment called rTMS can help improve symptoms for people with Parkinson's disease compared to a fake treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Jiangsu Province Nanjing Brain Hospital (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05850598 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of low-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the cerebellum in patients with Parkinson's disease. Participants will undergo either active or sham rTMS treatment, alongside assessments including resting state functional magnetic resonance imaging (fMRI), blood sampling, and the Unified Parkinson Disease Rating Scale (UPDRS) before and after treatment. The goal is to determine if rTMS can lead to improvements in Parkinson's symptoms compared to sham treatment. Data from these assessments will be compared to evaluate the potential benefits of rTMS.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 80 diagnosed with Parkinson's disease who are stable on their medication and have a Hoehn-Yahr stage of 3 or lower.

Not a fit: Patients with severe psychiatric disorders or other significant neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new non-invasive therapeutic option for improving symptoms in patients with Parkinson's disease.

How similar studies have performed: While the use of rTMS in neurological conditions is being explored, this specific application to the cerebellum for Parkinson's disease is relatively novel and has not been extensively tested.

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.

Where this trial is running

Nanjing, Jiangsu

• Nanjing Brain Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Yang Pan, M. D. — Jiangsu Province Nanjing Brain Hospital
• Study coordinator: Xiao-Yang Zhang, Ph.D.

Conditions Parkinson Disease; Transcranial Magnetic Stimulation