Retrospective Study on MR Imaging of ET and PD Patients Subjected With MRgFUS Thalamotomy

NCT04570046 | Completed

• 1 other identifier: MRgFUS-VIM-Retrospective-2020
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The technological advance of magnetic resonance-guided focused ultrasound (MRgFUS) has once again brought lesion therapy back to the clinical frontline for the treatment of movement disorder. Thus far, the safety of MRgFUS has been widely proven and has just been made available in China in late 2020. We attempted to analyze the neuroplasticity characteristics and altered neural circuit activity in patients subjected with MRgFUS thalamotomy via post-hoc retrospective analysis of archived MR imaging in our site, and to explore potential biomarkers that could be used to predict the treatment outcome.

Conditions

Movement Disorders

Keywords

Essential tremor; Parkinson disease; MRgFUS; Magnetic resonance imaging

Outcome Measures

Primary Outcomes (3)

• Tremor symptoms in ET/PD patients subject with MRgFUS thalamotomy.

  The change in the hand tremor score derived by summing the CRST ratings that evaluate hand tremor. Comparison will be performed from examinations at baseline and postoperative timepoints. According to the change of tremor performance after surgery, patients can be considered to be divided into whether there is effective tremor relieve or tremor recurrence.

  2 years

• Multimodal imaging spectrum features in ET/PD patients subject with MRgFUS thalamotomy.

  From T2, T2 Flair, DWI, ESWAN, 3D-T1; ESWAN and MRS manifests were mapped and numeralized in the brain atlas, and then were used to construct multiple-dimensional spectrum features of brain alterations after MRgFUS thalamotomy, including brain functional activity, brain structural connectivity, cerebral blood flow, and so on.

  2 years

• Clinical variables spectrum features linking to the tremor symptoms and imaging spectrum features.

  Medical records and test data of patients during hospitalization, including demographic characteristics, common comorbidity, hematological analysis, coagulation function, lipids profile, blood biochemistry, were used to construct clinical variables spectrum features. The distribution characteristics of postoperative tremor symptoms and imaging spectrum features were compared with the multi-dimensional matrix.

  2 years

Secondary Outcomes (1)

• Adverse events in ET/PD patients subject with MRgFUS thalamotomy.

  2 years

Study Arms (2)

TD-PD patients undergoing MRgFUS thalamotomy

A total of 10 patients with tremor dominant PD underwent MRgFUS thalamotomy. Their clinical and imaging data were collected.

MR-ET patients undergoing MRgFUS thalamotomy

A total of 58 patients with medication-resistant ET underwent MRgFUS thalamotomy. Their clinical and imaging data were collected.

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ET and PD patients subject with MRgFUS thalamotomy

You may not qualify if:

• Men and women age 22 years or older;
• A diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder;
• Intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
• Regarding PD patients, the ratio of mean Unified Parkinson Disease Rating Scale (UPDRS) tremor scores to the mean UPDRS postural instability/gait disorder scores equal or greater than 1.5;
• Able to communicate sensations during the ExAblate TcMRgFUS treatment;
• All MRI examination performed according to study protocol;
• Having complete medical history and clinical follow up;
• Imaging data can be processed.
• Subjects with unstable cardiac status;
• Severe hypertension (diastolic BP \> 100 on medication);
• Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc;
• Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease;
• Patient with severely impaired renal function;
• History of abnormal bleeding and/or coagulopathy;
• History of immunocompromise including those who are HIV positive;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

Location

Related Publications (2)

• Zhang D, Xiong Y, Lu H, Duan C, Huang J, Li Y, Bian X, Zhang D, Zhou J, Pan L, Lou X. Predicting tremor improvement after MRgFUS thalamotomy in essential tremor from preoperative spontaneous brain activity: A machine learning approach. Sci Bull (Beijing). 2024 Oct 15;69(19):3098-3105. doi: 10.1016/j.scib.2024.05.049. Epub 2024 Aug 16.

  PMID: 39191568 DERIVED

• Wang X, Wang S, Lin J, Zhang D, Lu H, Xiong Y, Deng L, Zhang D, Bian X, Zhou J, Pan L, Lou X. Gray matter alterations in tremor-dominant Parkinson's disease after MRgFUS thalamotomy are correlated with tremor improvement: a pilot study. Quant Imaging Med Surg. 2023 Jul 1;13(7):4415-4428. doi: 10.21037/qims-22-1403. Epub 2023 May 4.

  PMID: 37456281 DERIVED

MeSH Terms

Conditions

Movement Disorders; Essential Tremor; Parkinson Disease

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Xin Lou, MD/PhD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• LongSheng Pan, MD/PhD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Radiology Department

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 30, 2020
• Study Start: December 18, 2018
• Primary Completion: August 20, 2020
• Study Completion: August 31, 2020
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

CN (1)