Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With iNPH (iNPH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02495610|
Recruitment Status : Recruiting
First Posted : July 13, 2015
Last Update Posted : November 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Normal Pressure Hydrocephalus||Other: Gait analysis and MRI:||Not Applicable|
Idiopathic normal pressure hydrocephalus (iNPH) is an important differential diagnosis of dementia in the elderly patients. It is characterised by an enlargement of the ventricular system and can lead to cognitive deficits, gait disturbance and incontinence. Treatment consists of a ventriculoperitoneal shunt. A major challenge is the identification of patients who suffer from iNPH and who will benefit from shunt surgery. Typically, cerebrospinal fluid (CSF) is withdrawn by a spinal tap, and walking speed and steps per distance are measured before and thereafter. In patients who benefit from the test tap the diagnosis iNPH is made and the indication for shunt surgery is ascertained. The diagnostic procedure is not standardised.
Little is known about the examinations and time-points suited best to predict surgery outcome. Thus, patients may undergo surgery who do not benefit, and patients who would benefit may be missed.
This study aims at defining a diagnostic algorithm to improve the prediction of surgery outcome in patients supposed to suffer from iNPH. In 25 serial patients, motor function will be analysed in detail by functional tests and a treadmill-based analysis before and after the test tap at different time-points. In addition, neuropsychological tests and MRI investigations (DWI and pw) will be done, and patients will fill-out a micturition diary. Patients who do not respond to the test tap will be offered a lumbar drainage for continuous CSF release as diagnostic escalation with repeated tests thereafter. Patients who finally undergo shunt surgery will be re-assessed to identify those who responded to surgery. Thereby, post-hoc analyses will identify those parameter(s) that had the best predictive value for surgery outcome. To confirm the parameters derived from such exploratory analyses, these parameters will be validated in another series of 25 patients.
The results of this study have the potential to improve the clinical routine and to provide a strategic advantage for the University Hospital Zurich.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Prospective Single-centre Trial Investigating Novel Parameters for the Prediction of Ventriculoperitoneal Shunting Efficacy in Patients With Idiopathic Normal Pressure Hydrocephalus|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||August 2019|
Gait analysis and MRI
Other: Gait analysis and MRI:
- Gait Analysis on treadmill by foot print plate and overground walking by time keeping [ Time Frame: 3 months ]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)
- MRI [ Time Frame: 3 months ]a composite of fractional anisotropy, mean diffusivity, parallel diffusivity, radial diffusivity
- Urological function by micturition diary [ Time Frame: 3 months ]a composite of the following informations: number of voiding, number of incontinence episodes, number of urgency episodes
- Neuropsychology by validated testing [ Time Frame: 3 months ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495610
|Contact: Katja Reuter, MDemail@example.com|
|Contact: Jutta Sommerfeldfirstname.lastname@example.org|
|Zurich, Switzerland, 8091|
|Contact: Katja Reuter, MD +41442551111 email@example.com|
|Contact: Jutta Sommerfeld +41442555543 firstname.lastname@example.org|
|Principal Investigator:||Michael Weller, Prof.||University of Zurich|