The Efficacy of Repetitive Transcranial Magnetic Stimulation in Parkinson's Disease：A Randomized, Double-blind, Multicenter, Placebo-controlled Trial

Launched by ANHUI MEDICAL UNIVERSITY · Sep 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called repetitive transcranial magnetic stimulation (rTMS) on people with Parkinson's disease (PD). rTMS is a non-invasive therapy that uses magnetic fields to stimulate nerve cells in the brain. Previous smaller studies have suggested that rTMS could help improve symptoms of Parkinson's and possibly slow down the disease's progression. The goal of this trial is to get more detailed information about how effective rTMS is for treating PD.

To participate in this study, individuals must be at least 40 years old and have a specific level of Parkinson's symptoms. They should not have made any changes to their medications in the month before or during the trial, and they should be able to complete certain tests and treatments. However, people with certain medical conditions, those with specific brain injuries or implants, and pregnant or breastfeeding individuals won’t be eligible. Participants will be randomly assigned to either receive the rTMS treatment or a placebo (a treatment that looks like the real thing but has no active ingredients) without knowing which one they are getting. This helps researchers understand the true effects of rTMS. The trial is not yet recruiting participants, but it aims to provide valuable insights into a potential new way to help manage Parkinson's disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥40 years old
• • 2. Meet Movement Disorder Society standards;
• • 3. Have no history of drug adjustment within 4 weeks before and during treatment;
• • 4. The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4
• • 5. MMSE ≥24，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.
• Exclusion Criteria:
• • 1. Head MRI/CT ruled out focal brain injury or severe leukoencephalopathy (Fazekas grade 3);
• • 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 or first-degree relatives have 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.