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

NCT ID: NCT05624385

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2025-12-01

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.

Detailed Description

Patients:

Patients with medication-refractory ET and PD were included. Baseline materials, clinical rating scale for tremor (CRST) , 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:

1. Lesion appearance and volume are measured by T2, T2 Flair, DWI, ESWAN, 3D-T1;

2. ESWAN and MRS manifests the changes of iron deposition and metabolism #respectively;

3. ASL shows regional cerebral blood flow associated with the procedure;

4. DTI demonstrates the destruction of white matter integrity.

5. Rs-functional MRI reflects alterations of resting-state brain activity.

Treatment:

MRgFUS thalamotomy

Follow-up:

Baseline (MRI+clinical evaluation); 1-day, 1-month, 3-months, 6-months,1-year, 2-years (MRI+clinical evaluation).

Conditions

Movement Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRgFUS treatment

Group Type: EXPERIMENTAL

MRgFUS treatment

Intervention Type: DEVICE

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

Interventions

MRgFUS treatment

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

Intervention Type: DEVICE

Other Intervention Names

Thalamotomy

Eligibility Criteria

Inclusion Criteria

1. Men and women age 22 years or older;

2. Subjects are able and willing to agree to participate in the study and can accept all research visits;

3. 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;

4. Able to adapt to MRI system;

5. To tolerate operation with or without some form of sedative (e.g., awake sedation);

6. Able to communicate with the doctor during the operation;

7. Able to use the "Stop ultrasonic processing" button;

8. Skull density ratio (SDR) ≥ 0.28.

Exclusion Criteria

1. 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;

2. Pregnant woman;

3. Subjects with severely impaired renal function;

4. Subjects with unstable cardiac status or severe hypertension (diastolic BP > 100 on medication);

5. Subjects show behaviors consistent with alcohol or drug abuse;

6. History of abnormal bleeding and/or coagulopathy/ or intracranial hemorrhage;

7. Patients who received anticoagulant therapy or medications known to increase the risk of bleeding within the month prior to receiving focused ultrasound treatment;

8. Cerebrovascular disease (multiple CVA or CVA within 3 months);

9. Subjects with brain tumors.

10. 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).

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xin Lou

Deputy Director of Department of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chinese PLA General Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongqin Xiong, MD

Role: CONTACT

xiongyongqin118@163.com

+86 18518518771

Xin Lou, MD,PhD

Role: CONTACT

+86 18518518771

Facility Contacts

Yongqin Xiong, MD

Role: primary

xiongyongqin118@163.com

+86 18518518771

Xin Lou, MD/PhD

Role: backup

Other Identifiers

MRgFUS-Tremor Disorders

Identifier Type: -

Identifier Source: org_study_id