Medication-Refractory Tremor Dominant Idiopathic Parkinsons Disease
Conditions
Interventions
The proposed study will evaluate the safety and initial effectiveness of the ExAblate Transcranial thalamotomy of subjects with medication-refractory, idiopathic, tremor-dominant Parkinsons disease (T
Sponsors
Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 01 Men and women, age 20 years and older 02 Subjects who are able and willing to give informed consent and able to attend all study visits through 3 Months 03 Subjects with a diagnosis of idiopathic PD as confirmed from clinical history and examination by a movement disorder neurologist at the site 04 All subjects included in this study will have a TD PIGD ratio > 1.15 in the medicated ON state as calculated from the UPDRS formula as described by S, et. al., 74. 05 Subject demonstrates a resting tremor severity score of greater than or equal to 3 in the hand/arm as measured by the medicated ON MDS-UPDRS question 3.17 or a postural/action tremor greater than or equal to a 2 for question 3.15 or 3.16. 06 Significant disability due to PD tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities 07 Tremor remains disabling when medical therapy is optimal or not tolerated for the treatment of other cardinal signs of PD bradykinesia, rigidity, etc, as determined by a movement disorders neurologist at the site 08 Subjects should be on a stable dose of all PD medications for 30 days prior to study entry. 09 The thalamus must be apparent on MRI such that targeting of the Vim nucleus can be performed indirectly by measurement from a line connecting the anterior and posterior commissures of the brain. 010 Subject is able to communicate sensations during the ExAblate Transcranial procedure.
Exclusion criteria
Exclusion criteria: 1.Subjects with unstable cardiac status including: 2.Subjects exhibiting any behavior 3.Severe hypertension. 4.Subjects with standard contraindications for MR imaging 5.Significant claustrophobia that cannot be managed with mild medication. 6. Current medical condition resulting in abnormal bleeding and/or coagulopathy 7. Patient with severely impaired renal function with estimated glomerular filtration 8. Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound 9. Subjects with risk factors for intraoperative or postoperative bleeding 10 Subjects who have an Overall Skull Density Ratio of 0.30 or less as calculated from the screening CT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint measured will be safety of unilateral, 3Tesla, ExAblate Transcranial thalamotomy for TDPD as determined from adverse events recorded during the one year study period. | — |
Countries
Japan
Contacts
Public ContactEtsuko Shimizu
Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital Clinical Research Center
Outcome results
None listed