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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-28

Study Completion Date

2025-10-01

Brief Summary

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Randomized, double-blind, self-cross-over control (After the first visit, patients are divided into two groups, randomly receiving real stimulation/placebo stimulation. 10 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, TMS analysts, and video analysts.)

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Detailed Description

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Conditions

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Parkinson Disease, Idiopathic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Verum stimulation followed by Sham stimulation

Group Type EXPERIMENTAL

transcranial MR-guided focused ultrasound

Intervention Type 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.

Sham stimulation followed by Verum stimulation

Group Type EXPERIMENTAL

transcranial MR-guided focused ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Meets the clinical probable Parkinson's disease diagnostic criteria proposed by MDS-UPDRS;
* Disease duration of 4 years or less;
* Unmedicated or has been off medication for more than 12 hours, with H\&Y stage ≤ 2.

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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes