UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052904 |
|---|---|
| Receipt number | R000060361 |
| Scientific Title | A controlled, randomized, parallel-group, prospective study of lumbar-abdominal shunting for normal pressure hydrocephalus complicated by Parkinson's disease and related disorders. |
| Date of disclosure of the study information | 2023/11/26 |
| Last modified on | 2024/12/02 15:14:03 |
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Basic information
Public title
Random prospective study of lumbar-abdominal shunting for normal pressure hydrocephalus associated with Parkinson's disease.
Acronym
Shunt-PD study
Scientific Title
A controlled, randomized, parallel-group, prospective study of lumbar-abdominal shunting for normal pressure hydrocephalus complicated by Parkinson's disease and related disorders.
Scientific Title:Acronym
Shunt-PD study
Region
| Japan |
Condition
Condition
Parkinson's disease, Parkinson's disease with dementia, normal pressure hydrocephalus
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Idiopathic Normal Pressure Hydrocephalus (iNPH) is a treatable neurological disorder characterized by dementia, urinary incontinence, and gait disturbance that can be corrected by lumboperiotoneal shunt(LPS) surgery. It is estimated that there are approximately 1 million patients with iNPH in Japan, and the number of patients with iNPH is increasing in Japan as the population ages. However, we conducted a retrospective study of iNPH patients hospitalized over the past 10 years and found that iNPH is associated with Parkinson's disease (PD) and its related disorder, dementia of Lewy bodies (DLB), as well as progressive supranuclear palsy (PSP). We reported that DAT scans are useful for detecting these complications. Furthermore, LPS surgery was partially effective not only in patients with iNPH but also in those with PD complicated by iNPH. However, clinically, it is often difficult to differentiate whether the case is complicated or uncomplicated, and the effectiveness is not consistent in AD. There is no clear conclusion whether that shunt surgery is really effective in PD and its related diseases.
The purpose of this study is to confirm the results of this retrospective study in a prospective study. This study will elucidate the correlation between the improvement in specific clinical symptoms and the improvement in imaging (Evans index, DAT-SPECT, etc.). In addition, iNPH will be shown to be a potential disease-modifying therapy for PD and related diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
iNPH grading scale
Key secondary outcomes
3m up and go, Mini Mental Scale Examination, Frontary Assessment Battery,Trail making Tast, Wechsler Adult Intelligence Scale-Third Edition, Urinary drainage evaluation (urodynamics), Parkinsonnism (Dopa challenging test, MDS-Unified Parkinson's Disease Rating Scale part3)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The randomly selected lumbar-abdominal shunt non-operative group will undergo surgery after 6 months from diagnosis.
Interventions/Control_2
The randomly selected lumbar-abdominal shunt surgery group will undergo surgery within 3 months of diagnosis.
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have any or all of the following symptoms: gait disturbance, cognitive dysfunction, or urinary dysfunction, and meet the criteria of Evans' index > 0.3, will undergo nuclear medicine examination (head MRI, DaT-SPECT, IMP-SPECT, MIBG myocardial scintigraphy).
Patients with disproportionately enlarged subarachnoid-space hydrocephalus (DESH) and gait disturbance should undergo CSF examination.
For patients with symptoms of gait disturbance but no DESH, a tap test is performed and cognitive function tests (MMSE: Mini Mental Scale Examination, FAB: Frontal Assessment Battery, TMT: Trail making test), evaluation of urinary dysfunction (I-PSS: International prostate symptom score, OABSS: Overactive bladder symptom score, ICIQ-SF: International Consultation on Incontinence Questionnaire Short Form), evaluation of parkinsonism (Dopa challenging test, MDS UPDRS part III: MDS-Unified Parkinson's Disease Rating Scale part III, iNPHGS: iNPH grading score) are performed before and after (on the day of the tap test, 3 days later, and 7 days later), and if symptoms improve, a diagnosis of normal pressure hydrocephalus is made.
Key exclusion criteria
Select patients with no pre-existing subarachnoid hemorrhage, meningitis, head trauma, congenital hydrocephalus, or aqueductal stenosis.If the CSF test shows CSF amyloid-beta42 < 500 pg/ml, CSF total tau > 600 pg/ml, and CSF phosphorylated tau > 60 pg/ml, the patient is likely to have Alzheimer's disease and should be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Taiji |
| Middle name | |
| Last name | Tsunemi |
Organization
Juntendo University
Division name
Neurology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
t-tsunemi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyo |
| Middle name | |
| Last name | Shimada |
Organization
Juntendo University
Division name
Neurology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
t-oyamada@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hospital Ethics Committee Bureau, Soon Paradise Hospital, Soon Paradise University School of Medicine
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
kenkyu5858@juntendo.ac.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
順天堂大学順天堂医院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 26 | 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
Patients with iNPH + Parkinson's disease will be divided into two groups under the condition of random assignment: those who underwent lumbar-abdominal shunt surgery and those who did not undergo lumbar-abdominal shunt surgery.
All patients will undergo a gait test (3m up and go), cognitive function test (MMSE: Mini Mental Scale Examination, FAB: Frontal Assessment Battery, TMT: Trail making test) evaluation of urinary dysfunction (International prostate symptom score(I-PSS), Overactive bladder symptom score(OABSS), International Consultation on Incontinence Questionnaire Short Form(ICIQ-SF)), evaluation of parkinsonism (Dopa challenging test, MDS-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS part III), iNPHGS (iNPH grading score)) before and after 3, 6 and 12 months LPS surgery (at the same timing for the patients who did not undergo LPS surgery).
The patients with no LPS surgery group can be considered for lumbar-abdominal shunting LPS surgery at the 6-month follow-up evaluation or at any time during follow-up if their symptoms worsen. The specific criteria for determining whether a patient should undergo LPS surgery include 1) a worsening of 5 points or more on the MDS-UPDRS part III, 2) a prolonged gait test of 3 seconds or more, 3) an obvious worsening of activities of daily living, or 4) when the examiner or subject recognizes an obvious worsening of symptoms.
In addition, oral medications for Parkinson's disease, in principle, do not change during this trial.
All patients will undergo imaging re-evaluation with head MRI, DaT-SPECT, and IMP-SPECT at 12 months.
Adverse events
Outcome measures
Cognitive and mental status: MMSE, FAB, TMT
Motor symptoms: 3m up and go, MDS-UPDRS part III, iNPHGS score
Urinary disturbances: I-PSS; International prostate symptom score, OABSS; Overactive bladder symptom score, ICIQ-SF; International Consultation on Incontinence Questionnaire Short Form
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 05 | 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
| 2023 | Year | 11 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060361
