Parkinson's DiseaseNCT06002581
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
A study testing rTMS real stimulation stage1 and rTMS real stimulation stage 2 in people with Parkinson's Disease, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- rTMS real stimulation stage1 and rTMS real stimulation stage 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2023to 28 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200040
Xiaoying Zhu, MD, +86 13817659260, docxiaoying@163.com
About this study
Official title: Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep 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.
- Conditions
- Parkinson's Disease
- Being tested
- rTMS real stimulation stage1, rTMS shame stimulation stage1, rTMS real stimulation stage 2
- Keywords
- Parkinson's disease, slow-wave sleep, rTMS, motor symptom, progression
- Medical subject headings
- Parkinson Disease, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS real stimulation stage1Device
In the first stage, the early treatment group use low-frequency rTMS real stimulation,
rTMS shame stimulation stage1Device
In the first stage, the control group (delayed treatment group) all use sham stimulation.
rTMS real stimulation stage 2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| the early treatment group | Experimental | stage1+stage2 real stimulation Receives: Device: rTMS real stimulation stage1; Device: rTMS real stimulation stage 2 |
| the control group (delayed treatment group) | Other | stage1 sham stimulation + stage2 real stimulation Receives: Device: rTMS shame stimulation stage1; Device: rTMS real stimulation stage 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day14
Secondary outcomes (9)
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
Measured: Day28,Day56
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
Measured: Day14,Day28,Day56
Assessment of sleep structure in patients with Parkinson's disease
Use polysomnography (PSG) to record the proportion of slow-wave sleep
Measured: Day14,Day28,Day56
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
Measured: Day14,Day28,Day56
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
Measured: Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on cortical excitability
short-interval cortical inhibition(SICI)
Measured: Day14,Day28
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
Measured: Day14,Day28,Day56
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
Measured: Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on gait
Use a quantitative gait analysis system to analyze the change of gait
Measured: Day14,Day28,Day56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start3 Sep 2023
- Primary completion28 Jul 2026 (estimated)
- Study completion28 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoying Zhu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xiaoying Zhu, doctor, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002581
- Sponsor's protocol ID
- CCTR-2022B05
- Status last verified
- Dec 2025
- First submitted
- 11 Jul 2023
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep to Delay the Progression of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06002581
- Acronym / sponsor ID
- CCTR-2022B05
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, slow-wave sleep, rTMS, motor symptom, progression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 28 Jul 2026 (estimated)
- Study completion
- 28 Jul 2026 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the early treatment group | Experimental | Device: rTMS real stimulation stage1, Device: rTMS real stimulation stage 2stage1+stage2 real stimulation |
| the control group (delayed treatment group) | Other | Device: rTMS shame stimulation stage1, Device: rTMS real stimulation stage 2stage1 sham stimulation + stage2 real stimulation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMS real stimulation stage1In the first stage, the early treatment group use low-frequency rTMS real stimulation, | Device | the early treatment group |
| rTMS shame stimulation stage1In the first stage, the control group (delayed treatment group) all use sham stimulation. | Device | the control group (delayed treatment group) |
| rTMS real stimulation stage 2In the second stage, both the early treatment group and the control group (delayed treatment group) will be treated with true stimulation low-frequency rTMS. | Device | the control group (delayed treatment group), the early treatment group |
Primary outcome
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
9 secondary outcomes
Effects of low-frequency rTMS stimulation on motor symptoms
Time frame: Day28,Day56
Measurement of improved balance function in patients with Parkinson's disease
Time frame: Day14,Day28,Day56
Assessment of sleep structure in patients with Parkinson's disease
Time frame: Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on anxiety
Time frame: Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on cognition
Time frame: Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on cortical excitability
Time frame: Day14,Day28
Effects of low-frequency rTMS stimulation on depression
Time frame: Day14,Day28,Day56
Assessment of daytime sleepiness in patients with Parkinson's disease
Time frame: Day14,Day28,Day56
Effects of low-frequency rTMS stimulation on gait
Time frame: Day14,Day28,Day56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
Related trials for Parkinson's Disease
Enrolling by invitation
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
PARKINSON DISEASE (Disorder)
RecruitingPhase 1/2
Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
Parkinson's Disease
Active, not recruiting
MR-guided Focused Ultrasound Plus GCase
Parkinsons Disease
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Not yet recruitingPhase 1
Stanford University Neurofiber Study
PARKINSON DISEASE (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoying Zhu, doctor principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS real stimulation stage1 and rTMS real stimulation stage 2 in people with Parkinson's Disease, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoying Zhu, doctor (+86 21 63240090, docxiaoying@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Motor Function in PD by Low Frequency rTMS Stimulation (time frame: Day14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.