Last updated: April 3, 2023
Sponsor: Chinese PLA General Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Dystonias
Dyskinesias
Tic Disorders
Treatment
N/AClinical Study ID
NCT05624385
MRgFUS-Tremor Disorders
Ages 22-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 allresearch visits;
- A diagnosis of ET and PD as confirmed from clinical history and examination by aneurologist or neurosurgeon specialized in movement disorder and intolerance to sideeffects 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
Exclusion Criteria:
- Subjects with standard contraindications for MR imaging such as non-MRI compatibleimplanted metallic devices including cardiac pacemakers, size limitations, knownintolerance 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 onmedication);
- 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 riskof 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 stationaryposition during treatment (can be up to 2 hrs of total time).
Study Design
Total Participants: 20
Study Start date:
February 17, 2023
Estimated Completion Date:
December 01, 2025
Study Description
Connect with a study center
Chinese PLA General Hospital
Beijing,
ChinaActive - Recruiting
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