CompletedNot Applicable

Efficacy of Deep-coil Based Repetitive Transcranial Magnetic Stimulation in the Treatment of Parkinson's Disease With Freezing of Gait and Its Neural Regulation Mechanism Study of Resting-state Cerebral Blood Flow

China60 participantsStarted 2023-02-01

Plain-language summary

The protocol for repetitive transcranial magnetic stimulation (rTMS) in treating Parkinson's disease (PD) with freezing of gait (FOG) has not yet established an internationally unified standard, and the heterogeneity of treatment parameters is often the main factor leading to significant differences in efficacy. Based on descriptive analyses and existing data from studies with relatively small sample sizes, the current research primarily focuses on unilateral stimulation targets, without exploring the effectiveness of stimulating the bilateral primary motor centers for lower limbs (M1-LL). Moreover, most studies use figure-of-eight coils or circular coils, while deep-coil stimulation may be more effective for M1-LL. There is still a lack of research employing arterial spin labeling (ASL) imaging to explore the neural mechanisms of resting-state cerebral blood flow (CBF) regulation associated with rTMS treatment for FOG. Therefore, this research project will focus on improving the above - mentioned issues. The high - frequency stimulation of bilateral M1 - LL using a deep - coil (double - cone coil) will be selected. The sample size will be further expanded to evaluate the efficacy of rTMS in treating freezing of gait (FOG). Combined with the three - dimensional arterial spin labeling (3D - ASL) imaging technique, the changes in resting - state cerebral blood flow (CBF) before and after treatment will be analyzed to explore the possible neural mechanisms of rTMS in treating FOG.

Who can participate

Age range

45 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Meeting the clinical diagnostic criteria for Parkinson's disease established by the Movement Disorder Society (MDS) in 2015. * Aged between 45 and 70 years old, regardless of gender. * Regularly taking anti - Parkinson's disease medications for a long time (≥3 years), accompanied by freezing of gait, and with poor efficacy of medications; * A score of ≥24 on the Mini - Mental State Examination (MMSE). * Signing the informed consent form and being willing to actively cooperate with the treatment. Exclusion Criteria: * Freezing of gait caused by parkinsonism and parkinson plus syndromes. * Having a history of central nervous system diseases such as cerebral infarction, cerebral hemorrhage, leukoencephalopathy, and migraine. * Having been diagnosed with epilepsy or having had epileptic seizures. * Having undergone craniocerebral surgery, having cerebral aneurysms or arteriovenous malformations, having metal implants in the skull, or having had a cardiac pacemaker implanted. * Having a history of other mental illnesses or a family history of mental illnesses, such as schizophrenia, bipolar disorder, autism, mental retardation, depression, etc. * Having received rTMS treatment. * Severe PD (H\&Y grade ≥ 4). * Severe organ dysfunction or severe physical diseases.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Unified Parkinson's Disease Rating Scale

Timeframe: Within 24 hours before treatment, within 24 hours after treatment, and 1 month after treatment

Trial details

NCT IDNCT06888778

SponsorNingbo Medical Center Lihuili Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-12-01

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