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NCT Number: NCT04996992

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location contact

Hao-xuan Lu

CONTACT

[email protected]

+86-13044270958

Xin Lou, MD

CONTACT

About this study

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:

  • Lesion appearance and volume are measured by T2, T2 Flair, DWI, ESWAN, 3D-T1;
  • ESWAN and MRS manifests the changes of iron deposition and metabolism, respectively;
  • ASL shows regional cerebral blood flow associated with the procedure;
  • DTI demonstrates the destruction of white matter integrity.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

MR-guided focused ultrasound

Procedure

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

Primary outcomes

  1. primary efficacy outcome

    Time frame: 1 year

    The primary endpoints at 6 months and 1 year postoperatively were the Unified Parkinson's Disease Rating Scale (UPDRS) scores.

  2. primary safety outcome

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hao-xuan Lu

CONTACT

[email protected]

+86-13044270958

Xin Lou, MD

CONTACT

+86-13044270958

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Aug 9, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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