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

Launched by XINHUA HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Oct 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help manage motor symptoms in people with Parkinson's disease using a technique called Transcranial MR-guided Focused Ultrasound. Essentially, the trial will see if this method can improve movement problems that some patients experience. Participants in the study will be randomly assigned to receive either the real treatment or a placebo (a treatment that has no active effect) during their first visit. After 10 days, they will switch groups, so everyone gets a chance to experience both the real treatment and the placebo, without knowing which one they are receiving at any time.

To be eligible for this trial, participants should be diagnosed with Parkinson's disease for four years or less and be in the early stages of the disease. They should not currently be taking medication for Parkinson's disease or have been off their medication for at least 12 hours before the trial. However, people with a history of certain medical issues, such as strokes, dementia, or severe mental disorders, cannot participate. If you or a loved one is interested, it's important to know that the trial is not yet recruiting, so you will need to wait for it to start.

Gender

ALL

Eligibility criteria

• 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.