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

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease, Idiopathic

• Registration Number: NCT06639945
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary

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.)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Study Start: 2024-10-28
• Primary Completion: 2025-07-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
UPDRS-III	2 weeks and 4 weeks	Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Day 1 to 1 year. 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 Outcome Measures

Name	Time	Method
TMS parameters	2 weeks and 4 weeks	Resting Motor Threshold, Input-Output Curve, Cortical Silent Period, Short-latency Afferent Inhibition, SAI, Interhemispheric Inhibition, Long-term Potentiation.
cortical activation detected by fNIRS	2 weeks and 4 weeks	Using near-infrared brain imaging systems, have patients perform finger tapping, fist clenching, and forearm rotation movements to observe brain region activation.