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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002581
• Other study ID #: CCTR-2022B05
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2023
• Est. completion date: July 28, 2026

Study information

• Verified date: December 2023
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Xiaoying Zhu, doctor
• Phone: +86 21 63240090
• Email: docxiaoying[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: July 28, 2026
• Est. primary completion date: July 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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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Related Conditions & MeSH terms

• Disease Progression
• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• rTMS real stimulation stage1
In the first stage, the early treatment group use low-frequency rTMS real stimulation,
• rTMS shame stimulation stage1
In the first stage, the control group (delayed treatment group) all use sham stimulation.
• rTMS real stimulation stage 2
In the second stage, both the early treatment group and the control group (delayed treatment group) will be treated with true stimulation low-frequency rTMS.

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effects of low-frequency rTMS stimulation on brain connectivity in the PD brain	functional magnetic resonance imaging (fMRI) (Default mode network, DMN)	Day0,Day14,Day28
Other	Changes in salivary melatonin levels	salivary melatonin levels(Fasting)	Day0,Day14,Day28,Day56
Primary	Change of Motor Function in PD by Low Frequency rTMS Stimulation	the score of Unified Parkinson's Disease Rating Scale? (UPDRSIII)[off] The higher the score, the more severe the motor dysfunction	Day14
Secondary	Effects of low-frequency rTMS stimulation on motor symptoms	the score of Unified Parkinson's Disease Rating Scale? (UPDRSIII) [on] The higher the score, the more severe the motor dysfunction	Day28,Day56
Secondary	Measurement of improved balance function in patients with Parkinson's disease	the score of Berg Balance Scale (BBS)[0-56] The higher the score, the better the balance	Day14,Day28,Day56
Secondary	Assessment of sleep structure in patients with Parkinson's disease	Use polysomnography (PSG) to record the proportion of slow-wave sleep	Day14,Day28,Day56
Secondary	Effects of low-frequency rTMS stimulation on anxiety	the score of Hamilton Anxiety Rating Scale(HAMA)[0-64] The higher the score, the more anxious	Day14,Day28,Day56
Secondary	Effects of low-frequency rTMS stimulation on cognition	the score of Montreal Cognitive Assessment(Moca)[0-30] The lower the score, the more severe the cognitive dysfunction	Day14,Day28,Day56
Secondary	Effects of low-frequency rTMS stimulation on cortical excitability	short-interval cortical inhibition(SICI)	Day14,Day28
Secondary	Effects of low-frequency rTMS stimulation on depression	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	Day14,Day28,Day56
Secondary	Assessment of daytime sleepiness in patients with Parkinson's disease	the score of The Epworth Sleeping Scale(ESS)[0-24] The higher the score, the more lethargic	Day14,Day28,Day56
Secondary	Effects of low-frequency rTMS stimulation on gait	Use a quantitative gait analysis system to analyze the change of gait	Day14,Day28,Day56