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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Parkinson Disease, Idiopathic

Treatments: Device: transcranial MR-guided focused ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06639945

XHEC-C-2024-125-2-1

Details and patient eligibility

About

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.)

Enrollment: 20 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Verum stimulation followed by Sham stimulation

Experimental group

Treatment:

Device: transcranial MR-guided focused ultrasound

Sham stimulation followed by Verum stimulation

Experimental group

Treatment:

Device: transcranial MR-guided focused ultrasound