CompletedNot Applicable

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

China68 participantsStarted 2018-12-18

Plain-language 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 post-hoc retrospective analysis of archived MR imaging in our site, and to explore potential biomarkers that could be used to predict the treatment outcome.

Who can participate

Age range

22 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Men and women age 22 years or older;
. A diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder;
. Intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
. Regarding PD patients, the ratio of mean Unified Parkinson Disease Rating Scale (UPDRS) tremor scores to the mean UPDRS postural instability/gait disorder scores equal or greater than 1.5;
. Able to communicate sensations during the ExAblate TcMRgFUS treatment;
. All MRI examination performed according to study protocol;
. Having complete medical history and clinical follow up;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tremor symptoms in ET/PD patients subject with MRgFUS thalamotomy.

Timeframe: 2 years

Multimodal imaging spectrum features in ET/PD patients subject with MRgFUS thalamotomy.

Timeframe: 2 years

Clinical variables spectrum features linking to the tremor symptoms and imaging spectrum features.

Timeframe: 2 years

Trial details

NCT IDNCT04570046

SponsorChinese PLA General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-08-20

View on ClinicalTrials.gov More Movement Disorders trials

Plain-language summary

Who can participate

Age range

22 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Men and women age 22 years or older;
. A diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder;
. Intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
. Regarding PD patients, the ratio of mean Unified Parkinson Disease Rating Scale (UPDRS) tremor scores to the mean UPDRS postural instability/gait disorder scores equal or greater than 1.5;
. Able to communicate sensations during the ExAblate TcMRgFUS treatment;
. All MRI examination performed according to study protocol;
. Having complete medical history and clinical follow up;

What they're measuring

Tremor symptoms in ET/PD patients subject with MRgFUS thalamotomy.

Timeframe: 2 years

Multimodal imaging spectrum features in ET/PD patients subject with MRgFUS thalamotomy.

Timeframe: 2 years

Clinical variables spectrum features linking to the tremor symptoms and imaging spectrum features.

Timeframe: 2 years