UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033955 |
|---|---|
| Receipt number | R000038714 |
| Scientific Title | A Feasibility Clinical Trial of the Management of the Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinsons Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Transcranial System |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2020/03/02 18:18:43 |
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Basic information
Public title
A Feasibility Clinical Trial of the Management of the Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinsons Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Transcranial System
Acronym
PD002J
Scientific Title
A Feasibility Clinical Trial of the Management of the Medically Refractory Dyskinesia Symptoms of Advanced Idiopathic Parkinsons Disease With Unilateral Lesioning of the Globus Pallidum Using the ExAblate Transcranial System
Scientific Title:Acronym
PD002J
Region
| Japan |
Condition
Condition
Medically Refractory Dyskinesia Symptoms of Advanced 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 efficacy of using the ExAblate Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD medications in subjects who are over 20 years of age and considered medication refractory with advanced idiopathic Parkinsons disease .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
The proposed study will evaluate the safety, and initial efficacy of using the ExAblate Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD medications
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 efficacy of using the ExAblate Transcranial to create a unilateral lesion in the globus pallidus as an adjunct to PD medications and considered medication refractory with advanced idiopathic Parkinsons disease.
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
1. Men and women, age 20 years and older
2. Subjects who are able and willing to give informed consent and able to attend all study visits through 24 Months
3. Subjects with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site
4. Levodopa responsive as defined by at least a 30% reduction in MDS-UPDRS motor subscale in the ON vs OFF medication state.
5. MDS UPDRS score of 30 in the meds OFF condition
6. Disabling motor complications of PD on optimum medical treatment characterized dyskinesia or motor fluctuations (MDS-UPDRS item 4.2 score of 2 or 3 in the meds ON condition)
7. Predominant disability from one side of the body.
8. Subjects should be on a stable dose of all PD medications for 30 days prior to study entry.
9. Subject is able to communicate sensations during the ExAblate Neuro procedure.
Key exclusion criteria
1. Hoehn and Yahr stage in the on medication state of 3 or greater
2. Presence of other central neurodegenerative disease suspected on neurological examination.
3. Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
4. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
5. Presence of significant cognitive impairment defined as score 21 Unstable psychiatric disease,
6. Subjects with significant depression as determined following a comprehensive assessment by a neuropsychologist.
7. Subjects exhibiting any behavior consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM 4 .
8. 9.Subjects with unstable cardiac status including.
10.Severe hypertension
11.Current medical condition resulting in abnormal bleeding and or coagulopathy
12.Receiving anticoagulant
13. Subjects with risk factors for intraoperative or postoperative bleeding as indicated
14. Patient with severely impaired renal function with estimated glomerular filtration rate
15. Subjects with standard contraindications for MR imaging
16. Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment.
17. History of intracranial hemorrhage
18. History of multiple strokes, or a stroke within past 6 months
19. Subjects with a history of seizures within the past year
20. Subjects with brain tumors
21. Subjects with intracranial aneurysms requiring treatment or arterial venous malformations requiring treatment.
22. Pregnancy or lactation.
23. All patients with severe premorbid risks3 4 MDS UPDRS Part1 2
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tetsumasa |
| Middle name | |
| Last name | Kamei |
Organization
Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
Division name
neurology department
Zip code
2510041
Address
1-5-1,Kandai,Tsujido,Fujisawa,Kanagawa
TEL
0466-35-1177
tetsumasakam@ctmc.jp
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Shimizu |
Organization
Medical Corporation Tokushukai Shonanfujisawa Tokushukai hospital
Division name
Clinical Research Center
Zip code
2510041
Address
1-5-1,Kandai,Tsujido,Fujisawa,Kanagawa
TEL
0466-35-1177
Homepage URL
etsuko.shimizu@tokushukai.jp
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
Tokushuka group EC
Address
1-8-7 Koji-machi,Chiyoda-ku,Tokyo
Tel
0332634801
etsuko.shimizu@tokushukai.jp
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 | 12 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2021 | 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 | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038714
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