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

NCT05623644 | Unknown DMC

• 1 other identifier: MRgFUS-VIM-prospective-2022
• Study Type: observational
• Target: 200
• 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 Multiple MR Imaging study, 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 (4)

• Tremor measurement in ET/PD patients subject with MRgFUS thalamotomy

  The change in the hand tremor score derived by summing eight items of the CRST/UPDRS that evaluate hand tremor and ability to perform tasks will be evaluated for movement disorders subjects.

  5 years

• Adverse reactions in ET/PD patients subject with MRgFUS thalamotomy

  Adverse Events will be evaluated using Significant Clinical Complications for movement disorders subjects. Adverse Events will be reported and categorized by investigators as definitely, probably, possibly, or unrelated to the device or procedure and categorized by treatment group / treatment arm.

  5 years

• Imaging features in ET/PD patients subject with MRgFUS thalamotomy

  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 and structural network; Rs-functional MRI reflects alterations of resting-state brain activity and functional network; others.

  5 years

• Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients

  It has been reported in the previous literature that about 10%-50% of the patients with MRgFUS thalamotomy had recurrent symptoms after the operation. We mainly recorded the recurrence of tremor in patients and the clinical symptoms and signs associated with this process in a long-term longitudinal observation.

  5 years

Study Arms (2)

TD-PD patients undergoing MRgFUS thalamotomy

The imaging data from patients with tremor dominant PD underwent MRgFUS thalamotomy. Their clinical and imaging data were also collected.

MR-ET patients undergoing MRgFUS thalamotomy

The imaging data from patients with medication-resistant ET underwent MRgFUS thalamotomy. Their clinical and imaging data were also collected.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ET and PD patients subject with MRgFUS thalamotomy

You may qualify if:

• Any patient who intends to undergo MRgFUS thalamotomy for tremor control will be recruited for additional multimodal MR Imaging scranning；
• A clear diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder;
• Men and women age 18 years or older;
• Intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
• Able to communicate sensations during the ExAblate TcMRgFUS treatment;
• Having complete medical history and clinical follow up;
• MR Imaging scanning can be processed.

You may not qualify if:

• 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;
• Subjects with unstable cardiac status;
• Severe hypertension (diastolic BP \> 100 on medication);
• Patient with severely impaired renal function;
• History of abnormal bleeding and/or coagulopathy;
• History of immunocompromise including those who are HIV positive;
• History of intracranial hemorrhage;
• Cerebrovascular disease (multiple CVA or CVA within 6 months);
• Subjects with uncontrolled symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema);
• Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time);
• Significant claustrophobia that cannot be managed with mild medication;
• Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination;
• Presence of significant cognitive impairment;
• Subjects with life-threatening systemic disease;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Jiaji Lin

Beijing, 100853, China

Location

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: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Department of Radiology

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: November 21, 2022
• Study Start: September 30, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2024
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

CN (1)