MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's

Status Not yet recruiting

Clinical Trial Summary

To investigate the neural mechanism of Magnetic resonance-guided focused ultrasound (MRgFUS) Pallidothalamic Tractotomy in Parkinson's disease through multi-model MRI, and identify imaging biomarkers for triaging candidates and predicting the clinical outcomes. Parkinson's disease (PD) is the second most progressive neurodegenerative disease with many motor and non-motor symptoms, which brings heavy burden to the family and the society. MRgFUS pallidothalamic tractotomy allows to address all symptoms of PD without skull opening and with very limited tissue ablation, but with varying effectiveness. The unknown pathogenesis of PD has greatly contributed to this variance. Therefore, in order to optimize the clinical application of MRgFUS pallidothalamic tractotomy, it is important to reveal the pathogenesis of Parkinson's disease by using multiple modality MRI methods, and identify imaging biomarkers to triage suitable candidates and predict clinical outcomes.

Clinical Trial Description

Treatment scheme: All patients will first receive uni- or bilateral MRgFUS PTT. As to bilateral interventions, the second one will take place at least 6 months after the first PTT. Patients with unilateral intervention will be followed to 1 year. Patients with bilateral interventions will be followed to 1 year after the second intervention. Baseline clinical demographics, Unified Parkinson Disease Rating Scale (UPDRS), treatment parameters (energy, power, duration time, temperature, target location) , associated adverse effects were recorded. Imaging protocols: T2; T2 Flair; DWI; ESWAN; MRS; 3D ASL 2.0s; 3D-T1; DTI; rs-functional MRI Imaging evaluation: 1. Lesion appearance and volume are measured by T2, T2 Flair, DWI, ESWAN, 3D-T1; 2. ESWAN and MRS manifests the changes of iron deposition and metabolism, respectively; 3. ASL shows regional cerebral blood flow associated with the procedure; 4. DTI demonstrates the destruction of white matter integrity. 5. Rs-functional MRI reflects alterations of resting-state brain activity. Treatment: MRgFUS pallidothalamic tractotomy Follow-up: MRI + clinical evaluation: Baseline, 3-day, 1-week, 1-month, 3-months, 6-months,12-months ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04996992
Study type	Observational
Source	Chinese PLA General Hospital
Contact	Hao-xuan Lu
Phone	+86-13044270958
Email	plaluhaoxuan@163.com
Status	Not yet recruiting
Phase
Start date	August 15, 2021
Completion date	August 15, 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms