Clinical Trail of Transcranial MR-guided Focused Ultrasound in the Treatment of Motor Symptoms in Patients With Parkinson' Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- UPDRS-III
Study Overview
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. 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sham stimulation followed by Verum stimulation
Intervention: transcranial MR-guided focused ultrasound (Device)
Verum stimulation followed by Sham stimulation
Intervention: transcranial MR-guided focused ultrasound (Device)
Outcomes
Primary Outcomes
UPDRS-III
Time Frame: Beginning and end of each experimental session
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.
Secondary Outcomes
- cortical activation detected by scalp EEG(From baseline (pre-sonication) to 10 minutes post-sonication)
Investigators
Zhengguo Liu
Department of Neurology
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine