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 2018/08/29 15:22:09

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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

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 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


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

Value
https://center6.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