Clinical trial NCT04996992: MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease
Official title: Multimodal Magnetic Resonance Imaging Study for MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Parkinson Disease
Magnetic Resonance Imaging
Keywords: MR-guided focused ultrasound
pallidothalamic tractotomy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: primary efficacy outcome
timeFrame: 1 year
measure: primary safety outcome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Xin Lou, MD
role: STUDY_CHAIR
References: