MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04996992
• Other study ID #: MRgFUS-PTT-PD
• Status: Not yet recruiting
• Start date: August 15, 2021
• Est. completion date: August 15, 2026

Study information

• Verified date: July 2021
• Source: Chinese PLA General Hospital
• Contact: Hao-xuan Lu
• Phone: +86-13044270958
• Email: plaluhaoxuan[@]163.com
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: August 15, 2026
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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