Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson's Disease
• Interventions: Device: rTMS real stimulation stage1; Device: rTMS shame stimulation stage1; Device: rTMS real stimulation stage 2

• Registration Number: NCT06002581
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

At present, no drug therapy has been proven to delay the progression of Parkinson's disease (PD). rTMS, as a non-invasive neuromodulation method, can regulate Slow-wave sleep (SWS). SWS is recognized closely related to neurodegeneration. However, there has been no clinical studies on if rTMS could delay the progression of PD by regulating SWS.

The main purpose of this study is to explore the changes of SWS in non-rapid eye movement (NREM) sleep period in PD patients by using rTMS, and the relationship with potential improvements of SWS and motor symptom delay. The study aims to find a potential new treatment strategy to delay the neurodegenerative process in PD patients by modulating SWS by rTMS.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-21
• Study Start: 2023-09-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-10
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-07-28
• Study Completion: 2026-07-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the control group (delayed treatment group)	rTMS real stimulation stage 2	stage1 sham stimulation + stage2 real stimulation
the early treatment group	rTMS real stimulation stage1	stage1+stage2 real stimulation
the early treatment group	rTMS real stimulation stage 2	stage1+stage2 real stimulation
the control group (delayed treatment group)	rTMS shame stimulation stage1	stage1 sham stimulation + stage2 real stimulation

Primary Outcome Measures

Name	Time	Method
Change of Motor Function in PD by Low Frequency rTMS Stimulation	Day14	the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII)\[off\] The higher the score, the more severe the motor dysfunction

Secondary Outcome Measures

Name	Time	Method
Effects of low-frequency rTMS stimulation on motor symptoms	Day28,Day56	the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII) \[on\] The higher the score, the more severe the motor dysfunction
Effects of low-frequency rTMS stimulation on anxiety	Day14,Day28,Day56	the score of Hamilton Anxiety Rating Scale（HAMA)\[0-64\] The higher the score, the more anxious
Measurement of improved balance function in patients with Parkinson's disease	Day14,Day28,Day56	the score of Berg Balance Scale (BBS)\[0-56\] The higher the score, the better the balance
Assessment of sleep structure in patients with Parkinson's disease	Day14,Day28,Day56	Use polysomnography (PSG) to record the proportion of slow-wave sleep
Assessment of daytime sleepiness in patients with Parkinson's disease	Day14,Day28,Day56	the score of The Epworth Sleeping Scale(ESS)\[0-24\] The higher the score, the more lethargic
Effects of low-frequency rTMS stimulation on cognition	Day14,Day28,Day56	the score of Montreal Cognitive Assessment（Moca)\[0-30\] The lower the score, the more severe the cognitive dysfunction
Effects of low-frequency rTMS stimulation on cortical excitability	Day14,Day28	short-interval cortical inhibition(SICI)
Effects of low-frequency rTMS stimulation on depression	Day14,Day28,Day56	the score of Hamilton Depression Rating Scale（HAMD） Total score ≥ 20 points: may be mild or moderate depression; The higher the score, the more depressed
Effects of low-frequency rTMS stimulation on gait	Day14,Day28,Day56	Use a quantitative gait analysis system to analyze the change of gait

Trial Locations

Locations (1)

Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China