UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033940
Receipt No. 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 2018/08/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email shimizu@mirai-iryo.com

Sponsor
Institute Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
Institute
Department

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
Email

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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 30 Day
Date of IRB
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
2018 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038695

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.