MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease; Magnetic Resonance Imaging
• Intervention / Treatment: Procedure: MR-guided focused ultrasound

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

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease

Description

Inclusion Criteria:

1. Regardless of sex, aged 30 or above, hope to treat bilateral motor symptoms and receive the other side treatment plan at the 6th month;
2. Subjects are able and willing to give informed consent and can participate in whole study visits;
3. It was clinically diagnosed as Parkinson's disease and confirmed by functional neurosurgeons;
4. The subjects should respond to levodopa;
5. In the off-medication state, the subjects' MDS-UPDRS scores were 30 or more.

Exclusion Criteria:

1. The subjects scored 3 or more in the pull-back test;
2. Parkinson's disease symptoms were suspected as the side effects of antipsychotics;
3. severe cognitive impairment confirmed by neuropsychologists;
4. subjects with other neurodegenerative diseases;
5. Subjects with unstable mental illness, defined as active, uncontrolled depression, schizophrenia, delusions, hallucinations or suicide intention;
6. Pregnant or lactating women;
7. Subjects with alcohol or drug abuse;
8. Subjects with unstable heart condition or severe hypertension;
9. Subjects with a history of abnormal bleeding or clotting.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson's disease; The cohort includes patients with Parkinson's disease who underwent MRgFUS pallidothalamic tractotomy (PTT).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary efficacy outcome	The primary endpoints at 6 months and 1 year postoperatively were the Unified Parkinson's Disease Rating Scale (UPDRS) scores.	1 year
primary safety outcome	Primary safety outcome was assessed by monitoring the incidence and severity of the procedure-related adverse events from the procedure through 1 year after treatment for all patients.	1 year

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 15, 2021
• Primary Completion (ANTICIPATED): August 15, 2023
• Study Completion (ANTICIPATED): August 15, 2026

Study Registration Dates

• First Submitted: July 31, 2021
• First Submitted That Met QC Criteria: July 31, 2021
• First Posted (ACTUAL): August 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2021
• Last Update Submitted That Met QC Criteria: July 31, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: pallidothalamic tractotomy; MR-guided focused ultrasound
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: MRgFUS-PTT-PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No