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NCT Number: NCT06002581

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Xiaoying Zhu, MD

CONTACT

[email protected]

+86 13817659260

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the clinically definite or clinically probable PD according to the MDS 2015 version.
  • 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.
  • Hoehn-Yahr stages 1-4.
  • The dose of levodopa drug therapy was stable three weeks before enrollment and during the follow-up period.
  • Right-handed.
  • The patient signed a written informed consent.

Exclusion criteria

  • Any form of Parkinsonism other than primary PD.
  • Those who have received neurosurgical intervention or stereotaxic brain surgery for PD, or have previously received TMS treatment.
  • Cognitive dysfunction (MMSE ≤ 24 points) or those who cannot cooperate with the scale score.
  • Persons with mental disabilities.
  • Pregnant women.
  • There are contraindications for rTMS treatment.
  • There are contraindications for MRI examination.
  • Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; BMI>=30.
  • 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.
  • 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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Treatment and study plan

rTMS real stimulation stage1

Device

In the first stage, the early treatment group use low-frequency rTMS real stimulation,

rTMS shame stimulation stage1

Device

In the first stage, the control group (delayed treatment group) all use sham stimulation.

rTMS real stimulation stage 2

Device

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.

Primary outcomes

  1. Change of Motor Function in PD by Low Frequency rTMS Stimulation

    Time frame: Day14

    the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII)[off] The higher the score, the more severe the motor dysfunction

Secondary outcomes

  1. Effects of low-frequency rTMS stimulation on motor symptoms

    Time frame: Day28,Day56

    the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII) [on] The higher the score, the more severe the motor dysfunction

  2. Measurement of improved balance function in patients with Parkinson's disease

    Time frame: Day14,Day28,Day56

    the score of Berg Balance Scale (BBS)[0-56] The higher the score, the better the balance

  3. Assessment of sleep structure in patients with Parkinson's disease

    Time frame: Day14,Day28,Day56

    Use polysomnography (PSG) to record the proportion of slow-wave sleep

  4. Effects of low-frequency rTMS stimulation on anxiety

    Time frame: Day14,Day28,Day56

    the score of Hamilton Anxiety Rating Scale(HAMA)[0-64] The higher the score, the more anxious

  5. Effects of low-frequency rTMS stimulation on cognition

    Time frame: Day14,Day28,Day56

    the score of Montreal Cognitive Assessment(Moca)[0-30] The lower the score, the more severe the cognitive dysfunction

  6. Effects of low-frequency rTMS stimulation on cortical excitability

    Time frame: Day14,Day28

    short-interval cortical inhibition(SICI)

  7. Effects of low-frequency rTMS stimulation on depression

    Time frame: 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

  8. Assessment of daytime sleepiness in patients with Parkinson's disease

    Time frame: Day14,Day28,Day56

    the score of The Epworth Sleeping Scale(ESS)[0-24] The higher the score, the more lethargic

  9. Effects of low-frequency rTMS stimulation on gait

    Time frame: Day14,Day28,Day56

    Use a quantitative gait analysis system to analyze the change of gait

Other outcomes

  1. Effects of low-frequency rTMS stimulation on brain connectivity in the PD brain

    Time frame: Day0,Day14,Day28

    functional magnetic resonance imaging (fMRI) (Default mode network, DMN)

  2. Changes in salivary melatonin levels

    Time frame: Day0,Day14,Day28,Day56

    salivary melatonin levels(Fasting)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoying Zhu, doctor

CONTACT

[email protected]

+86 21 63240090

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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