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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorAnhui Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • transcranial magnetic stimulation

    Other intervention

    The stimulations were performed by MagStim Rapid2.

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: Real rTMS groupExperimental treatment 1 intervention
Group B: Sham rTMS groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
baseline; day 8; week 5;week 9

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
baseline; day 8; week 5;week 9

Other outcomes

Sponsors and contacts

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