ClinicalTrials.gg
RecruitingNCT06002581Updated Dec 9, 2025

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

An interventional study of rTMS real stimulation stage1 and rTMS shame stimulation stage1 in Parkinson's Disease, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 278 studies in Parkinson Disease with a site in China — 129 open to participants now, 136 under way, 3 of them phase 3. Parkinson Disease · China.

Planned enrollment
92nd of 210
56 · median 48
Started
2023
with 29 others
No phase
115 of 278
59 open now
Primary completion
2026-07
later than 51 of 135 live
Registered
143rd of 278
by date

Among the 278 studies in Parkinson Disease with a site in China, this one is the 92nd largest by planned enrollment of the 210 interventional ones that give a count, is one of 30 that started in 2023, is one of 115 with no phase, reaches primary completion later than 51 of the 135 other live ones, and was the 143rd registered.

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 56 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Open to participants now

129 of the 278 studies in Parkinson Disease with a site in China are open now, in 12 countries. Each count lists the studies.

All 129 open studies →

Who these studies take

Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.

This study: 50 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 278 studies in Parkinson Disease with a site in China, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Parkinson's Disease

Keywords

  • Parkinson's disease
  • slow-wave sleep
  • rTMS
  • motor symptom
  • progression
04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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 ( ≤ 24 points) or those who cannot cooperate with the scale score.
  4. Persons with mental disabilities.
  5. Pregnant women.
  6. There are for rTMS treatment.
  7. There are contraindications for MRI examination.
  8. Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; >=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 form; and other circumstances that the researcher considers inappropriate to participate in the study.

    -

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
56 participants (estimated)

Study arms

  • Experimental
    the early treatment group

    stage1+stage2 real stimulation

    Device: rTMS real stimulation stage1 · Device: rTMS real stimulation stage 2

  • Other
    the control group (delayed treatment group)

    stage1 sham stimulation + stage2 real stimulation

    Device: rTMS shame stimulation stage1 · Device: rTMS real stimulation stage 2

Interventions

  • DevicerTMS real stimulation stage1

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

  • DevicerTMS shame stimulation stage1

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

  • DevicerTMS 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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: Day14

Secondary outcomes

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

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

    Time frame: Day28,Day56

  2. 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

    Time frame: Day14,Day28,Day56

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

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

    Time frame: Day14,Day28,Day56

  4. 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

    Time frame: Day14,Day28,Day56

  5. 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

    Time frame: Day14,Day28,Day56

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

    short-interval cortical inhibition(SICI)

    Time frame: Day14,Day28

  7. 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

    Time frame: Day14,Day28,Day56

  8. 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

    Time frame: Day14,Day28,Day56

  9. Effects of low-frequency rTMS stimulation on gait

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

    Time frame: Day14,Day28,Day56

Other outcomes

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

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

    Time frame: Day0,Day14,Day28

  2. Changes in salivary melatonin levels

    salivary melatonin levels(Fasting)

    Time frame: Day0,Day14,Day28,Day56

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Jul 2026, 34 months after the start.

Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 34 months is above that.

Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 11, 2023
First posted
Aug 21, 2023
StartActual
Sep 3, 2023
Primary completionEst.
Jul 28, 2026
CompletionEst.
Jul 28, 2026
Last update
Dec 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06002581
Responsible party
Xiaoying Zhu (associate chief physician of neurology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Aug 21, 2023
Start date
Sep 3, 2023
Primary completion
Jul 28, 2026 (estimated)
Completion
Jul 28, 2026 (estimated)
Last update
Dec 9, 2025

Study contacts

Xiaoying Zhu, doctor
Contact
docxiaoying@163.com
+86 21 63240090
Xiaoying Zhu, doctor
principal investigator · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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