NCT06888778Completed
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
Source: ClinicalTrials.gov · Last updated 4 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 17 Feb 2025
- Start date
- 1 Feb 2023
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Diseases
- Parkinson disease
- NCT number
- NCT06888778
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 1 Feb 2023 to the primary completion date, 1 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having received rTMS treatment.
Other illness
- 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.
- Severe organ dysfunction or severe physical diseases.
Other
- Severe PD (H\&Y grade ≥ 4).
Who the study is looking for
- 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.
Age in the registry: 45 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ningbo Medical Center Li Huili Hospital, Ningbo, China Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.