NCT04996992

MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease

Multimodal Magnetic Resonance Imaging Study for MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Parkinson Disease
• Magnetic Resonance Imaging

Interventions

Type	Name	Description
PROCEDURE	MR-guided focused ultrasound	MR-guided focused ultrasound pallidothalamic tractotomy is a minimally invasive and effective procedure for thetreatment of Parkinson's disease(PD) patients.

Timeline

• Start date: 2021-08-15
• Primary completion: 2023-08-15
• Completion: 2026-08-15
• First posted: 2021-08-09
• Last updated: 2021-08-09

Locations

1 site across 1 country: China