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Random prospective study of lumbar-abdominal shunting for normal pressure hydrocephalus associated with Parkinson's disease.

A controlled, randomized, parallel-group, prospective study of lumbar-abdominal shunting for normal pressure hydrocephalus complicated by Parkinson's disease and related disorders. - Shunt-PD study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052904
Enrollment
100
Registered
2023-11-26
Start date
2021-05-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson&#39

Interventions

The randomly selected lumbar-abdominal shunt non-operative group will undergo surgery after 6 months from diagnosis. The randomly selected lumbar-abdominal shunt surgery group will undergo surgery wit

Sponsors

Juntendo University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
iNPH grading scale

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactTomoyo Shimada

Juntendo University Neurology

t-oyamada@juntendo.ac.jp03-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026