Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT01772693
Eligibility Criteria:
Inclusion Criteria:
* Men and women, age 30 years and older
* Subjects who are able and willing to give informed consent and able to attend all study visits
* Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site
* Subject demonstrates a severe resting tremor or postural/action as measured by UPDRS
* Subject exhibits a significant disability from their PD tremor despite medical treatment
* Subjects should be on a stable dose of all PD medications for 30 days prior to study entry
* Subject is able to communicate sensations during the ExAblate Transcranial procedure
Exclusion Criteria:
* Subjects with unstable cardiac status
* Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
* Severe hypertension
* Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
* Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
* Significant claustrophobia that cannot be managed with mild medication
* Current medical condition resulting in abnormal bleeding and/or coagulopathy
* Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
* History of intracranial hemorrhage
* History of multiple strokes, or a stroke within past 6 months
* Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
* Are participating or have participated in another clinical trial in the last 30 days
* Subjects unable to communicate with the investigator and staff
* Subjects with a history of seizures within the past year
* Subjects with brain tumors
* Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment
* Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT01772693
Study Brief:
Protocol Section:
NCT01772693