Idiopathic Normal Pressure Hydrocephalus Clinical Trial
— iNPHOfficial title:
A Prospective Single-centre Trial Investigating Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With Idiopathic Normal Pressure Hydrocephalus
Verified date | May 2024 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
INPH is a chronic, progressive disease characterised by enlarged ventricles in the absence of elevated intracranial pressure. Patients often present with the Hakim triad comprising gait disturbance, dementia and urinary incontinence. Treatment consists of ventriculoperitoneal (VP) shunting reducing the cerebrospinal fluid (CSF) volume in the central nervous system (CNS); a generally safe and well tolerated procedure nevertheless invasive in nature and associated with surgical risk. The currently used diagnostic algorithms to predict surgery outcome by testing patients before and after a diagnostic spinal tap temporarily reducing the CSF volume in the CNS are of wide variability and limited validity. Developing measures to accurately diagnose and select patients for intervention is thus of great importance. The objective of this study is to define and validate a diagnostic algorithm for the selection of patients with symptoms compatible with iNPH for shunt surgery.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | December 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | Inclusion Criteria: - Informed consent. - Age 50 years or above - Impaired walking function for at least 3 months, onset at/ after 40 years of age. - MRI or CT with enlarged ventricular system (Evans' index =0.30) without evidence of moderate or severe cortical atrophy. - Eligible for shunt surgery. - Eligible for analysis of gait, neuropsychological and urological function. - Subjects must be able to understand the patient information sheet and comply with the requirements of the protocol. Exclusion Criteria: - Previous intracranial disorder or surgery. - Contraindications to surgery or MRI - Contraindications to the testing of gait, bladder or neuropsychological function. - Presence of concomitant disease which might reasonably account for the clinical symptoms or radiological findings. - Worsening of walking function secondary to any other condition occurring during the study. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Hakim S, Adams RD. The special clinical problem of symptomatic hydrocephalus with normal cerebrospinal fluid pressure. Observations on cerebrospinal fluid hydrodynamics. J Neurol Sci. 1965 Jul-Aug;2(4):307-27. doi: 10.1016/0022-510x(65)90016-x. No abstract available. — View Citation
Marmarou A, Young HF, Aygok GA, Sawauchi S, Tsuji O, Yamamoto T, Dunbar J. Diagnosis and management of idiopathic normal-pressure hydrocephalus: a prospective study in 151 patients. J Neurosurg. 2005 Jun;102(6):987-97. doi: 10.3171/jns.2005.102.6.0987. — View Citation
Relkin N, Marmarou A, Klinge P, Bergsneider M, Black PM. Diagnosing idiopathic normal-pressure hydrocephalus. Neurosurgery. 2005 Sep;57(3 Suppl):S4-16; discussion ii-v. doi: 10.1227/01.neu.0000168185.29659.c5. — View Citation
Stolze H, Kuhtz-Buschbeck JP, Drucke H, Johnk K, Diercks C, Palmie S, Mehdorn HM, Illert M, Deuschl G. Gait analysis in idiopathic normal pressure hydrocephalus--which parameters respond to the CSF tap test? Clin Neurophysiol. 2000 Sep;111(9):1678-86. doi: 10.1016/s1388-2457(00)00362-x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gait Analysis on treadmill by foot print plate and overground walking by time keeping | a composite of the following measurements: Step width, step length, Foot rotation, double stance phase, cadence, velocity (Timed 25 Foot Walk, endurance (6 minute walking test) | 3 months | |
Secondary | MRI | a composite of fractional anisotropy, mean diffusivity, parallel diffusivity, radial diffusivity | 3 months | |
Secondary | Urological function by micturition diary | a composite of the following informations: number of voiding, number of incontinence episodes, number of urgency episodes | 3 months | |
Secondary | Neuropsychology by validated testing | a composite of response inhibition and switching (stroop test), working memory (wechsler memory scale), verbal fluency (Regensburg word fluency), figural fluency (number of unique designs and repetitions of the same figure), divided and focused attention (TMT A, TMT B) | 3 months |
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