A Feasibility Study of MRgFUS in the Treatment of Therapy-Resistant Tremor-Related Patients With Low SDR Value

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Yongqin Xiong, MD
xiongyongqin118@163.com
+86 18518518771
Backup
Xin Lou, MD,PhD
+86 18518518771
Time Frame
Start Date: 2023-02-17
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 20
Treatments
Experimental: MRgFUS treatment
Sponsors
Leads: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov

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