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Recruiting NCT06383247

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

No phase Interventional Parkinson Disease Transcranial Magenetic Stimualtion Supplementary Motor Area

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcranial magnetic stimulation.
Who it may be relevant to
Registry conditions: Parkinson Disease, Transcranial Magenetic Stimualtion, Supplementary Motor Area. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Other transcranial magnetic stimulation
    The stimulations were performed by MagStim Rapid2.

Primary outcome measures

  • Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores [Time frame: baseline; day 8; week 5;week 9]
Secondary outcome measures (12)
  • Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅰ scores [Time frame: baseline; day 8; week 5;week 9]
  • Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores [Time frame: baseline; day 8; week 5;week 9]
  • Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores [Time frame: baseline; day 8; week 5;week 9]
  • Hoehn-Yahr(H-Y) scale [Time frame: baseline; day 8; week 5;week 9]
  • The timed up and go test (TUG) [Time frame: baseline; day 8; week 5;week 9]
  • 20 meters walking [Time frame: baseline; day 8; week 5;week 9]
  • Non-motor symptom scale（NMSS） [Time frame: baseline; day 8; week 5;week 9]
  • Parkinson's Disease questionnaire-39 items（PDQ-39） [Time frame: baseline; day 8; week 5;week 9]
  • Hamilton Depression Scale-17（HAMD-17） [Time frame: baseline; day 8; week 5;week 9]
  • Hamilton Anxiety Scale（HAMA） [Time frame: baseline; day 8; week 5;week 9]
  • Pittsburgh sleep quality index（PSQI） [Time frame: baseline; day 8; week 5;week 9]
  • Mini-Mental State Examination（MMSE） [Time frame: baseline; day 8; week 5;week 9]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Cognitive Neuropsychology Lab Anhui Medical University — Hefei

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; PMID 41896996

Identifiers

NCT: NCT06383247 · AMU-PD-multicenter

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗