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.)

Study Overview

• Status: Completed
• Conditions: Parkinson Disease, Idiopathic
• Intervention / Treatment: Device: transcranial MR-guided focused ultrasound

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200092
    • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verum stimulation followed by Sham stimulation	Device: transcranial MR-guided focused ultrasound; 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.
Experimental: Sham stimulation followed by Verum stimulation	Device: transcranial MR-guided focused ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UPDRS-III	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.	Beginning and end of each experimental session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cortical activation detected by scalp EEG	Resting-state scalp EEG was recorded before, throughout, and following sonication.	From baseline (pre-sonication) to 10 minutes post-sonication

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Actual): November 5, 2025
• Study Completion (Actual): November 5, 2025

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: XHEC-C-2024-125-2-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No