Clinical Trail of Transcranial MR-guided Focused Ultrasound in the Treatment of Motor Symptoms in Patients With Parkinson' Disease

Randomized, double-blind, self-cross-over control (After the first visit, patients are divided into two groups, randomly receiving real stimulation/placebo stimulation. 14 days later, during the second visit, a cross-over occurs: patients who received real stimulation in the first visit will receive placebo stimulation in the second visit, and vice versa. The grouping situation remains blinded for the patients, EEG analysis, and video analysis.)

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Key information

Conditions

Parkinson Disease, Idiopathic Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, 200092, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Meets the clinical probable Parkinson's disease diagnostic criteria proposed by MDS-UPDRS;
a stable dosage of L-DOPA medications for at least one month;
no contraindications for MRI.

Exclusion criteria

History of stroke or seizures, dementia; previous surgical interventions for Parkinson's disease; contraindications for TMS (such as cardiac pacemakers, transcranial implants, and metal implants); severe mental disorders such as depression or psychosis; inability to understand the study procedures; use of antipsychotic medications; pregnancy.

Treatment and study plan

transcranial MR-guided focused ultrasound

Device

MRI-guided transcranial focused ultrasound (MRgFUS) combines magnetic resonance imaging (MRI) with focused ultrasound to target specific areas in the brain non-invasively. MRgFUS allows for treatment without surgical incisions, leading to fewer risks and a quicker recovery. MRI provides real-time imaging that helps precisely locate and treat affected brain regions, such as the thalamus or globus pallidus.The procedure allows for continuous monitoring of the treatment effects, enabling adjustments as needed.

Primary outcomes

UPDRS-III

Time frame: Beginning and end of each experimental session

Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impairment.

Secondary outcomes

cortical activation detected by scalp EEG

Time frame: From baseline (pre-sonication) to 10 minutes post-sonication

Resting-state scalp EEG was recorded before, throughout, and following sonication.

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Oct 15, 2024
Registry last updated: May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed