UnknownNot Applicable

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

China200 participantsStarted 2022-09-30

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 Multiple MR Imaging study, and to explore potential biomarkers that could be used to predict the treatment outcome.

Who can participate

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.

Inclusion criteria

. Any patient who intends to undergo MRgFUS thalamotomy for tremor control will be recruited for additional multimodal MR Imaging scranning；
. A clear diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder;
. Men and women age 18 years or older;
. Intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
. Able to communicate sensations during the ExAblate TcMRgFUS treatment;
. Having complete medical history and clinical follow up;
. MR Imaging scanning can be processed.

Exclusion criteria

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 measurement in ET/PD patients subject with MRgFUS thalamotomy

Timeframe: 5 years

Adverse reactions in ET/PD patients subject with MRgFUS thalamotomy

Timeframe: 5 years

Imaging features in ET/PD patients subject with MRgFUS thalamotomy

Timeframe: 5 years

Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients Postoperative symptom recurrence of patients

Timeframe: 5 years

Trial details

NCT IDNCT05623644

SponsorChinese PLA General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11-30

View on ClinicalTrials.gov More Movement Disorders trials

Plain-language summary

Who can participate

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.

Inclusion criteria

. Any patient who intends to undergo MRgFUS thalamotomy for tremor control will be recruited for additional multimodal MR Imaging scranning；
. A clear diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder;
. Men and women age 18 years or older;
. Intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
. Able to communicate sensations during the ExAblate TcMRgFUS treatment;
. Having complete medical history and clinical follow up;
. MR Imaging scanning can be processed.

Exclusion criteria

What they're measuring

Tremor measurement in ET/PD patients subject with MRgFUS thalamotomy

Timeframe: 5 years

Adverse reactions in ET/PD patients subject with MRgFUS thalamotomy

Timeframe: 5 years

Imaging features in ET/PD patients subject with MRgFUS thalamotomy

Timeframe: 5 years