Using magnetic stimulation to improve motor symptoms in Parkinson's disease

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

This study is testing if a new brain stimulation technique can help improve movement problems in people with Parkinson's disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 290 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Anhui Medical University (other)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06383247 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) in alleviating motor symptoms in patients with Parkinson's disease. It is a multi-center, double-blind, randomized controlled trial conducted across various hospital centers in China. The study focuses on stimulating the supplementary motor area of the brain using a specific stimulation protocol over a course of 7 days, with the aim of observing changes in clinical symptoms before and after the intervention.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 and older diagnosed with idiopathic Parkinson's disease who meet specific clinical criteria.

Not a fit: Patients with secondary parkinsonism syndromes or those with severe brain injuries or implants that are incompatible with magnetic stimulation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve motor symptoms and potentially delay the progression of Parkinson's disease.

How similar studies have performed: Previous small sample studies have shown promising results for rTMS in treating Parkinson's disease, suggesting potential for success in this larger trial.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Hefei, Anhui

• Cognitive Neuropsychology Lab Anhui Medical University — Hefei, Anhui, China (RECRUITING)

Study contacts

• Principal investigator: Panpan Hu, M.D. — The First Affiliated Hospital of Anhui Medical University
• Study coordinator: Panpan Hu, M.D.

Conditions: Parkinson Disease, Transcranial Magenetic Stimualtion, Supplementary Motor Area, transcranial magenetic stimualtion, supplementary motor area