UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033940 |
|---|---|
| Receipt number | R000038695 |
| Scientific Title | A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease. |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2025/03/05 14:45:08 |
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Basic information
Public title
A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease.
Acronym
PD001J
Scientific Title
A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease.
Scientific Title:Acronym
PD001J
Region
| Japan |
Condition
Condition
Medication-Refractory Tremor Dominant Idiopathic Parkinsons Disease
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The proposed study will evaluate the safety and initial effectiveness of the ExAblate Transcranial thalamotomy of subjects with medication-refractory, idiopathic, tremor-dominant Parkinson's disease (TDPD)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
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.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
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 (TDPD)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsumasa kamei |
Organization
Medical Corporation Tokushukai Shonanfujisawa
Tokushukai hospital
Division name
neurology department
Zip code
Address
1-5-1,Kandai,Tsujido,Fujisawa,Kanagawa
TEL
0466-35-1177
tetsumasakam@ctmc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Etsuko Shimizu |
Organization
Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
Division name
Clinical Research Center
Zip code
Address
1-5-1,Kandai,Tsujido,Fujisawa,Kanagawa
TEL
0466-35-1177
Homepage URL
shimizu@mirai-iryo.com
Sponsor or person
Institute
Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
Institute
Department
Personal name
Funding Source
Organization
InSightec
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038695
