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 range22 Years – 99 Years

SexALL

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;
✕. Imaging data can be processed.

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 range22 Years – 99 Years

SexALL

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;
✕. Imaging data can be processed.

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