MRgFUS Thalamotomy for Therapy-Resistant Tremor-related Disease With Low SDR Value

NCT05624385 | Unknown

• 1 other identifier: MRgFUS-Tremor Disorders
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A study to evaluate the effectiveness and safety of ExAblate transcranial MRgFUS Thalamotomy treatment of medication refractory tremor-related diseases subjects with low skull density ratio (SDR) value. Essential tremor (ET) and Parkinson disease (PD) are the most prevalent tremor disorders. ET, considered as a pure tremor disease, is characterized by upper limb intention or postural tremor, while PD is characterized by a variety of motor and non-motor symptoms, among them rest tremor. A number of studies have demonstrated that Magnetic resonance-guided focused ultrasound (MRgFUS) thalamotomy is a minimally invasive and effective procedure suitable for medication-refractory tremor in patients with ET and patients with PD. However, the skull is the main barrier to MRgFUS thalamotomy therapy and patients are screened by calculating SDR value before treatment. The US FDA recommended SDR value \>0.45±0.05 as the inclusion criterion for screening patients with tremor treated by MRgFUS system. However, about 20%-50% of patients with SDR value are lower than this standard, which makes this part of patients excluded and unable to accept this treatment with many advantages such as non-invasive, no need for general anesthesia, and no need for hardware implantation. Therefore, this study intended to evaluate the safety and effectiveness of MRgFUS thalamotomy in the treatment of tremor-related patients with low SDR value, so as to provide clinical basis for more patients with tremor to benefit from this treatment.

Conditions

Movement Disorders

Keywords

Essential tremor; Parkinson disease; MRgFUS

Outcome Measures

Primary Outcomes (1)

• 1.1 Safety To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of subjects during 2-year follow-up.

  All AE reported by the investigator are classified as: definitely relevant, very likely relevant, probably relevant, probably not relevant or definitely not relevant to the product under study, where definitely relevant, very likely relevant, possibly relevant are classified as relevant, probably not relevant and definitely not relevant are classified as irrelevant.

  2 years

Secondary Outcomes (2)

• 2.1. Safety To evaluate the incidence and severity of adverse events (AE/AEs) after ExAblate Transcranial MRgFUS treatment of subjects at 24 hours, 1 month, 3 months, 6 months, 12 months, and 2 years follow-up.

  2 years

• 2.2. Effectiveness

  2 years

Study Arms (1)

MRgFUS treatment

EXPERIMENTAL

Device: MRgFUS treatment

Interventions

MRgFUS treatment DEVICE

ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Tremor-Related Subjects

Also known as: Thalamotomy

MRgFUS treatment

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 22 years or older;
• Subjects are able and willing to agree to participate in the study and can accept all research visits;
• A diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder and intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
• Able to adapt to MRI system;
• To tolerate operation with or without some form of sedative (e.g., awake sedation);
• Able to communicate with the doctor during the operation;
• Able to use the "Stop ultrasonic processing" button;
• Skull density ratio (SDR) ≥ 0.28.

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, known intolerance or allergies to the MRI contrast agent (e.g.Gadolinium or Magnevist) including advanced kidney disease, etc;
• Pregnant woman;
• Subjects with severely impaired renal function;
• Subjects with unstable cardiac status or severe hypertension (diastolic BP \> 100 on medication);
• Subjects show behaviors consistent with alcohol or drug abuse;
• History of abnormal bleeding and/or coagulopathy/ or intracranial hemorrhage;
• Patients who received anticoagulant therapy or medications known to increase the risk of bleeding within the month prior to receiving focused ultrasound treatment;
• Cerebrovascular disease (multiple CVA or CVA within 3 months);
• Subjects with brain tumors.
• Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 2 hrs of total time).

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, China

RECRUITING

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

Central Study Contacts

Yongqin Xiong, MD

CONTACT

+86 18518518771; xiongyongqin118@163.com

Xin Lou, MD,PhD

CONTACT

+86 18518518771

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Department of Radiology

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 22, 2022
• Study Start: February 17, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

CN (1)