Back to resultsMRgFUS Thalamotomy for Therapy-Resistant Tremor-related Disease With Low SDR Value
Primary Purpose
Movement Disorders
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MRgFUS treatment
Sponsored by
About this trial
This is an interventional treatment trial for Movement Disorders focused on measuring Essential tremor, Parkinson disease, MRgFUS
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRgFUS treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
To evaluate the incidence of unexpected adverse device events (UADE) within 2 years after the treatment of the study product.
2.2. Effectiveness
The effectiveness will be evaluated by the hand tremor subscore (on a scale ranging from 0 to 32 when the dominant hand is treated and 0 to 28 points when the nondominant hand is treated, with higher scores indicating more severe tremor), which was derived from the Clinical Rating Scale for Tremor (CRST) . Both the treatment side and the non-treatment side of the subject will be evaluated.
Clinical evaluation will be conducted at the following time points: at screening, at baseline, and 1, 3, 6, 12 months, and 2 years after treatment.
Full Information
NCT ID
NCT05624385
First Posted
November 10, 2022
Last Updated
April 3, 2023
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05624385
Brief Title
MRgFUS Thalamotomy for Therapy-Resistant Tremor-related Disease With Low SDR Value
Official Title
A Feasibility Study of MRgFUS in the Treatment of Therapy-Resistant Tremor-Related Patients With Low SDR Value
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Movement Disorders
Keywords
Essential tremor, Parkinson disease, MRgFUS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRgFUS treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRgFUS treatment
Other Intervention Name(s)
Thalamotomy
Intervention Description
ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Tremor-Related Subjects
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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.
Description
To evaluate the incidence of unexpected adverse device events (UADE) within 2 years after the treatment of the study product.
Time Frame
2 years
Title
2.2. Effectiveness
Description
The effectiveness will be evaluated by the hand tremor subscore (on a scale ranging from 0 to 32 when the dominant hand is treated and 0 to 28 points when the nondominant hand is treated, with higher scores indicating more severe tremor), which was derived from the Clinical Rating Scale for Tremor (CRST) . Both the treatment side and the non-treatment side of the subject will be evaluated.
Clinical evaluation will be conducted at the following time points: at screening, at baseline, and 1, 3, 6, 12 months, and 2 years after treatment.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongqin Xiong, MD
Phone
+86 18518518771
Email
xiongyongqin118@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Lou, MD,PhD
Phone
+86 18518518771
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongqin Xiong, MD
Phone
+86 18518518771
Email
xiongyongqin118@163.com
First Name & Middle Initial & Last Name & Degree
Xin Lou, MD/PhD
12. IPD Sharing Statement
Learn more about this trial
MRgFUS Thalamotomy for Therapy-Resistant Tremor-related Disease With Low SDR Value
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