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Parkinson DiseaseNCT06383247

The Efficacy and Safety of Precision REpetitive Transcranial Magnetic Stimulation in Alleviating Motor Symptom in Parkinson's Disease

A study testing transcranial magnetic stimulation in people with Parkinson Disease and Transcranial Magenetic Stimualtion, run by Anhui Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
transcranial magnetic stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
290 participants
Where
1 siteChina
Study dates
6 Dec 2024to 31 Dec 2028
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 40 years old;
  • Meet the diagnostic criteria for idiopathic Parkinson's disease (MDS Diagnostic Criteria for Parkinson's Disease (2015 Edition))[1];
  • Have no history of drug adjustment within 4 weeks before treatment and the entire study period;
  • The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4;
  • MMSE ≥22,able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.

Who cannot join

  • Previously head MRI/CT was focal brain injury or severe leukoencephalopathy (Fazekas grade 3 and above);
  • Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonism combined with parkinsonism, drug parkinsonism, etc.);
  • Severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment;
  • There are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.
  • The person has a history of epilepsy, unexplained loss of consciousness, or are taking anticonvulsant drugs to treat epileptic seizures;
  • Diagnosed with a neuropsychiatric disorder other than PD
Show all 10Show fewer
  • Have a history of drug abuse or drug use;
  • Participants in any clinical trial within the previous 6 month;
  • Pregnant/lactating women or subjects (including men) who have a birth plan within 6 months;
  • Other conditions deemed unsuitable for inclusion by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Panpan Hu, M.D. contact

+8613515602285

hpppanda9@126.com

Kai Wang, Ph.D. contact

+8655162923704

wangkai1964@126.com

China1 site, 1 recruiting
  • Cognitive Neuropsychology Lab Anhui Medical University

    Hefei, Anhui, 230032

    panpan hu, M.D., +8655162923704, hpppanda9@126.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled Trial (PRESS-PD)

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion, our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country.

Read the detailed description

This is a multi-center, double-blind, randomized controlled study that will be implemented in multiple hospital centers in China. In this study, the supplementary motor area (SMA) of the dominant hemisphere was selected as the stimulation target, and continuous theta burst stimulation (cTBS) sequence contact stimulation was used for a course of continuous stimulation for 7 days to observe the changes in clinical symptoms before and after the intervention.

Keywords
Parkinson Disease, transcranial magenetic stimualtion, supplementary motor area
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06383247
Study groupRoleWhat they receive
Real rTMS groupExperimentalParticipants will receive active transcranial magnetic stimulation (TMS) daily for 1 week.
Receives: Other: transcranial magnetic stimulation
Sham rTMS groupPlacebo comparatorParticipants will receive sham transcranial magnetic stimulation (TMS) daily for 1 week
Receives: Other: transcranial magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores

    This is an very common clinical motor estimating scale with 18 items and 140' in total. Higher scores indicate worse symptoms.

    Measured: baseline; day 8; week 5;week 9

Secondary outcomes (13)
  1. Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅰ scores

    MDS-UPDRS I is used to evaluate the daily life non-motor symptom experience of patients with Parkinson's disease. It includes 13 items with a total score of 52 points. Higher scores indicate worse symptoms.

    Measured: baseline; day 8; week 5;week 9

  2. Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores

    MDS-UPDRS II is used to evaluate patients' experience of daily life motor symptoms, such as speech function, eating ability, daily living ability (eating, dressing, hygiene), tremor, walking, etc. It includes 13 items with a total score of 52 points. Higher scores indicate worse symptoms.

    Measured: baseline; day 8; week 5;week 9

  3. Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores

    The MDS-UPDRS IV questionnaire assesses the severity of two motor complications in patients: dyskinesias and motor fluctuations, combined with previously known and objective information. It includes 6 items with a total score of 24 points. Higher scores indicate worse symptoms.

    Measured: baseline; day 8; week 5;week 9

  4. Hoehn-Yahr(H-Y) scale

    H-Y scale is a standardized instrument used to evaluate the severity of Parkinson's disease. It employs a scoring system that ranges from 1 to 5, with higher scores indicating greater severity of clinical symptoms and a corresponding decline in quality of life. The assessment criteria primarily consider the number of limbs affected, the presence of balance disturbances, and the extent of functional impairment in daily living activities. This scale is valued for its simplicity and practicality, making it a prevalent tool in clinical trials for evaluating Parkinson's disease symptoms.

    Measured: baseline; day 8; week 5;week 9

  5. The timed up and go test (TUG)

    TUG measures in seconds how long it takes the subject to rise from the chair, walk 3 meters, turn around, walk back to the chair, and sit down. The test is often used to assess walking and balance in older adults. This also applies to evaluating the severity of walking and balance symptoms in patients with Parkinson's disease.

    Measured: baseline; day 8; week 5;week 9

  6. 20 meters walking

    The 20-meter walking test measured the time it took for the subject to turn, continue to walk to the original place and turn back after walking from the upright position for 10m in seconds, and recorded the total number of steps. The test is also used to assess walking and balance in people with Parkinson's disease, but the distance is longer and more stable. Both tests were recorded on video with the patient's consent.

    Measured: baseline; day 8; week 5;week 9

  7. Non-motor symptom scale(NMSS)

    NMSS is a validated assessment tool for non-motor symptoms in patients with PD. The scale consists of nine domains, each carrying a separate domain score, with higher scores indicating more severe symptoms for that domain. The score for each domain is derived by multiplying the severity and frequency ratings on a scale of 0-4. The total NMSS score is the sum of the nine field scores.

    Measured: baseline; day 8; week 5;week 9

  8. Parkinson's Disease questionnaire-39 items(PDQ-39)

    PDQ-39 is a self-rating scale for clinical evaluation of the quality of life of patients with Parkinson's disease, which consists of 8 dimensions and 39 items. The rating ranges from 0 to 4. The PDQ-39 total score is the sum of the 39 project scores.

    Measured: baseline; day 8; week 5;week 9

  9. Hamilton Depression Scale-17(HAMD-17)

    HAMD-17 is commonly used in clinical trials to assess the severity of depression and is the gold standard for diagnosing depression. The scale was used to assess the depressive symptoms of patients through conversation and observation by uniformly trained evaluators, including 17 items, scoring on a 0-4 scale. If the total score is <7, there is no depression; A score between 7 and 17 indicates mild depression. A score between 18 and 24 indicates moderate depression; If the total score is more than 24, it indicates major depression.

    Measured: baseline; day 8; week 5;week 9

  10. Hamilton Anxiety Scale(HAMA)

    HAMA is a tool commonly used to diagnose anxiety disorders. The evaluators with standardized training evaluated the anxiety symptoms of the patients by way of conversation and observation, which were mainly divided into physical anxiety and mental anxiety, with a total of 14 sub-items, the score range was 0-4, and the sum of the scores of each sub-item was the total score of the scale. If the total score is more than 29, it may be severe anxiety; Over 21 points, there must be significant anxiety; If more than 14 points, definitely have anxiety; More than 7 points, may have anxiety; Less than 7, no anxiety.

    Measured: baseline; day 8; week 5;week 9

  11. Pittsburgh sleep quality index(PSQI)

    PSQI was used to evaluate the sleep quality of patients with sleep disorders and general people in the past month. The scale consists of 4 fill-in-the-blank questions and 5 multiple choice questions, and the fifth multiple choice question includes 10 multiple choice questions, for a total of 18 questions. The questions assessed patients' sleep quality from seven factors, including: subjective sleep quality, time to fall asleep, sleep duration, habitual sleep efficiency, sleep disorders, hypnotic medications, and daytime function. The total score of the scale is the sum of the 7 factor scores. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

    Measured: baseline; day 8; week 5;week 9

  12. Mini-Mental State Examination(MMSE)

    MMSE is a widely utilized assessment tool in both clinical practice and scientific research for the evaluation of cognitive function and mental status. This scale measures several cognitive domains, including orientation, attention and calculation, delayed recall, verbal function, and visual-spatial abilities. The total score on the MMSE ranges from 0 to 30, with higher scores indicating better cognitive performance. Typically, a score below 24 is indicative of potential cognitive impairment.

    Measured: baseline; day 8; week 5;week 9

  13. Clinical Global Impression(CGI)

    CGI is used to evaluate the clinical treatment effect and is conducted by uniformly trained evaluators. The scale consists of three parts: severity of illness (SI), global improvement (GI) and efficacy index (EI). When evaluating SI, it is necessary to evaluate the severity of the patient's disease according to the relevant experience of patients with the same diagnosis in the past. When evaluating GI, the evaluator should compare the current condition of the patient with that at the time of enrollment to evaluate the treatment effect of the patient. Both SI and GI are evaluated on a scale of 0-7. Evaluation of EI includes two aspects, namely efficacy and side effects caused by treatment. Both were rated on a scale of 1-4. EI= efficacy score/side effect score. This scale integrates the severity of the patient's disease and the effect of treatment, which is helpful for following up the patient's condition changes.

    Measured: baseline; day 8; week 5;week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2024
  2. Study start6 Dec 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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, Investigator
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06383247
Sponsor's protocol ID
AMU-PD-multicenter
Status last verified
Jun 2025
First submitted
22 Apr 2024
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen X, Ji GJ, Ye R, Sun J, Hu L, Han J, Yu L, Li Y, Wu J, Zhu M, Cheng J, Liu P, Liu T, Sun L, Yuan J, Liang Z, Du J, Gong L, Zhang K, Sun H, Zhong P, Wang K, Hu P. The efficacy and safety of precision repetitive transcranial magnetic stimulation in alleviating motor symptoms in Parkinson's disease (PRESS-PD): a randomized, double-blind, multicenter, placebo-controlled trial. Trials. 2026 Mar 27;27(1):356. doi: 10.1186/s13063-026-09579-6.

    PubMed 41896996

Questions about this trial

What is this clinical trial studying?

A study testing transcranial magnetic stimulation in people with Parkinson Disease and Transcranial Magenetic Stimualtion, run by Anhui Medical University 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 5 inclusion and 10 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 17 Jun 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. Some participants in this study may receive a placebo. 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 Panpan Hu, M.D. (+8613515602285, hpppanda9@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores (time frame: baseline; day 8; week 5;week 9). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06383247, which also lists 1 linked publication.

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 17 Jun 2025.

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