Using rTMS to Delay Progression of Parkinson's Disease

Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep to Delay the Progression of Parkinson's Disease

This study is testing whether a non-invasive treatment called rTMS can improve sleep and help people with Parkinson's Disease feel better and slow down their symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06002581 on ClinicalTrials.gov

What this trial studies

This study investigates the use of repetitive transcranial magnetic stimulation (rTMS) to regulate slow-wave sleep (SWS) in patients with Parkinson's Disease (PD). It aims to explore how changes in SWS may correlate with improvements in motor symptoms and potentially delay the progression of neurodegeneration associated with PD. The study will involve real and sham rTMS interventions to assess their effects on sleep patterns and motor function. By focusing on a non-invasive approach, the research seeks to identify a new treatment strategy for managing PD.

Who should consider this trial

Good fit: Ideal candidates are Chinese Han individuals aged 50 to 80 with clinically definite or probable Parkinson's Disease in Hoehn-Yahr stages 1-4.

Not a fit: Patients with other forms of Parkinsonism, cognitive dysfunction, or those who have previously undergone TMS treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel non-invasive treatment option to slow the progression of Parkinson's Disease.

How similar studies have performed: While the use of rTMS has been explored in various contexts, this specific application for delaying Parkinson's Disease progression through SWS modulation is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Meet the clinically definite or clinically probable PD according to the MDS 2015 version.
2. Chinese Han population (three generations), age greater than or equal to 50 years old, less than or equal to 80 years old, male or female.
3. Hoehn-Yahr stages 1-4.
4. The dose of levodopa drug therapy was stable three weeks before enrollment and during the follow-up period.
5. Right-handed.
6. The patient signed a written informed consent.

Exclusion Criteria:

1. Any form of Parkinsonism other than primary PD.
2. Those who have received neurosurgical intervention or stereotaxic brain surgery for PD, or have previously received TMS treatment.
3. Cognitive dysfunction (MMSE ≤ 24 points) or those who cannot cooperate with the scale score.
4. Persons with mental disabilities.
5. Pregnant women.
6. There are contraindications for rTMS treatment.
7. There are contraindications for MRI examination.
8. Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; BMI\>=30.
9. Patients who are addicted to alcohol, taking SSRIs, TCAs, sedative hypnotics, histamine antagonists and other drugs and food that may affect NREM and REM sleep structure.
10. Those who are unwilling to participate in the study or unable to sign the informed consent form; and other circumstances that the researcher considers inappropriate to participate in the study.

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Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Xiaoying Zhu, doctor — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Xiaoying Zhu, doctor

Conditions: Parkinson's Disease, Parkinson's disease, slow-wave sleep, rTMS, motor symptom, progression