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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Parkinson's Disease

Treatments: Device: rTMS real stimulation stage 2; Device: rTMS real stimulation stage1; Device: rTMS shame stimulation stage1

Study type: Interventional

Funder types: Other

Identifiers

NCT06002581

CCTR-2022B05

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

    -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

56 participants in 2 patient groups

the early treatment group

Experimental group

Description:

stage1+stage2 real stimulation

Treatment:

Device: rTMS real stimulation stage1

Device: rTMS real stimulation stage 2

the control group (delayed treatment group)

Other group

Description:

stage1 sham stimulation + stage2 real stimulation

Treatment:

Device: rTMS shame stimulation stage1

Device: rTMS real stimulation stage 2