Parkinson Disease, Idiopathic
Conditions
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.)
Interventions
DEVICEtranscranial 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.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UPDRS-III | 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
| Measure | Time frame | Description |
|---|---|---|
| cortical activation detected by scalp EEG | From baseline (pre-sonication) to 10 minutes post-sonication | Resting-state scalp EEG was recorded before, throughout, and following sonication. |
Countries
China
Outcome results
None listed