scholarly journals P.208 Pilot Study of a Multi-center, Randomized, Blinded, Placebo-Controlled Trial of Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus

2021 ◽  
Vol 48 (s3) ◽  
pp. S79-S80
Author(s):  
MG Hamilton ◽  
M Williams ◽  
R Holubkov ◽  
S Nagel ◽  
J Wisoff ◽  
...  
Keyword(s):  
Normal Pressure Hydrocephalus ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Normal Pressure ◽  
Idiopathic Normal Pressure Hydrocephalus ◽  
Active Group ◽  
Research Network ◽  
Gait Velocity ◽  
Shunt Surgery ◽  
Ventriculoperitoneal Shunting

Background: To describe preliminary results of a multi-center, randomized, blinded, placebo-controlled, pilot trial of shunt surgery in idiopathic normal pressure hydrocephalus (iNPH). Methods: Five sites of the Adult Hydrocephalus Clinical Research Network (AHCRN) randomized 18 patients scheduled for ventriculoperitoneal shunting based on CSF-drainage response. Patients were randomized to a Codman® Certas® Plus valve with SiphonGuard at either setting 4 (Active, N=9) or setting 8/”virtual off” (Placebo, N=9). Patients and assessors were blinded to the shunt setting. Outcomes included 10-meter gait velocity, cognitive function, and bladder activity scores. The prespecified primary analysis compared changes in 4-month gait velocity in the Active versus Placebo groups. Placebo-set shunts were then blindly adjusted to the active setting and all patients underwent 8 and 12-month post-surgical assessment. Results: At 4-months, gait velocity increased by 0.28±0.28m/s in the Active Group and 0.04±0.17m/s in the Placebo Group (p=0.071). Overactive Bladder (OAB-q) scores significantly improved in the Active versus Placebo groups (p=0.007). At 8 months, Placebo gait velocity increased by 0.36±0.27m/s and was comparable to the Active Group (0.40±0.20m/s; p=0.56). Conclusions: This AHCRN study shows a trend suggesting gait velocity improves more at an Active shunt setting than a Placebo shunt setting and demonstrates the feasibility of a placebo-controlled trial in iNPH.

Relationship between gait parameters and MR imaging in idiopathic normal pressure hydrocephalus patients after shunt surgery

2018 ◽  
Vol 61 ◽  
pp. 163-168
Author(s):  
Ippei Kitade ◽  
Ryuhei Kitai ◽  
Hiroyuki Neishi ◽  
Ken-ichiro Kikuta ◽  
Seiichiro Shimada ◽  
...  
Keyword(s):  
Mr Imaging ◽  
Normal Pressure Hydrocephalus ◽  
Normal Pressure ◽  
Idiopathic Normal Pressure Hydrocephalus ◽  
Shunt Surgery ◽  
Gait Parameters

Cerebral microdialysis and intracranial pressure monitoring in patients with idiopathic normal-pressure hydrocephalus: association with clinical response to extended lumbar drainage and shunt surgery

2010 ◽  
Vol 112 (2) ◽  
pp. 414-424 ◽  
Author(s):  
Per K. Eide ◽  
Milo Stanisic
Keyword(s):  
Intracranial Pressure ◽  
Normal Pressure Hydrocephalus ◽  
Wave Amplitude ◽  
Cerebral Metabolism ◽  
Normal Pressure ◽  
Idiopathic Normal Pressure Hydrocephalus ◽  
Clinical Severity ◽  
Cerebral Microdialysis ◽  
Shunt Surgery ◽  
Lumbar Drainage

Object This study was performed in patients with idiopathic normal-pressure hydrocephalus (iNPH) to monitor cerebral metabolism with microdialysis (MD) and intracranial pressure (ICP) readings, and relate to the clinical responses to extended lumbar drainage (ELD) and shunt surgery. Methods The baseline levels of MD metabolites and ICP were monitored overnight in 40 consecutive patients with iNPH. In a subset of 28 patients, monitoring was continued during 3 days of ELD. Thirty-one patients received a ventriculoperitoneal shunt. The clinical severity of iNPH was determined before and then 3 and 6–12 months after shunt surgery. Results Altered levels of MD markers (lactate, pyruvate, lactate/pyruvate ratio, glutamate, and/or glycerol) were seen in all patients at baseline; these improved during ELD. Despite normal static ICP (mean ICP), the pulsatile ICP (the ICP wave amplitude) was increased in 24 patients (60%). Only the level of the ICP wave amplitude differentiated the ELD and/or shunt responders from nonresponders. Conclusions The MD monitoring indicated low-grade cerebral ischemia in patients with iNPH; during ELD, cerebral metabolism improved. The pulsatile ICP (the ICP wave amplitude) was the only variable differentiating the clinical responders from the nonresponders. The authors suggest that the pulsatile ICP reflects the intracranial compliance and that CSF diversion improves the biophysical milieu of the nerve cells, which subsequently may improve their biochemical milieu.

Ventriculoperitoneal Shunting of Idiopathic Normal Pressure Hydrocephalus Increases Midbrain Size: A Potential Mechanism for Gait Improvement

Neurosurgery ◽  
2006 ◽  
Vol 59 (4) ◽  
pp. 847-851 ◽  
Author(s):  
J Mocco ◽  
Matthew I. Tomey ◽  
Ricardo J. Komotar ◽  
William J. Mack ◽  
Steven J. Frucht ◽  
...  
Keyword(s):  
Normal Pressure Hydrocephalus ◽  
Ventriculoperitoneal Shunt ◽  
Medical Center ◽  
Normal Pressure ◽  
Idiopathic Normal Pressure Hydrocephalus ◽  
Cross Sectional ◽  
Mean Values ◽  
Shunt Placement ◽  
Ventriculoperitoneal Shunting ◽  
The Mean

Abstract OBJECTIVE: Idiopathic normal pressure hydrocephalus (INPH) is characterized by a classic clinical triad of symptoms, including dementia, urinary incontinence, and gait disturbance. Recent work has demonstrated that the maximal midbrain anteroposterior (AP) diameter is significantly smaller in patients with INPH than in healthy, age-matched controls. The current study was undertaken to determine the effect of ventriculoperitoneal shunt placement on midbrain dimensions in INPH patients. METHODS: Twelve consecutive INPH patients undergoing ventriculoperitoneal shunt placement with pre- and postoperative computed tomographic scans at the Columbia University Medical Center were enrolled. Each patient's pre- and postoperative maximum AP and left-to-right diameters of the midbrain at the pontomesencephalic junction were independently measured in a blinded fashion by two of the authors. The average value of each dimension was computed by calculating the mean values of the measurements of the two observers. RESULTS: Both the mean AP diameter (preoperative mean, 2.06 ± 0.04 cm; postoperative mean, 2.27 ± 0.05; P = 0.0007) and left-to-right diameter (preoperative mean, 2.80 ± 0.07; postoperative mean, 3.03 ± 0.08; P = 0.0029) increased from pre- to postoperative imaging. The approximate cross-sectional area determined as the product of AP and left-to-right diameters also increased from pre- to postoperative images (preoperative mean, 5.79 ± 0.22 cm2; postoperative mean, 6.90 ± 0.25 cm2; P = 0.00049). CONCLUSION: This study provides supportive evidence that midbrain cytoarchitecture may play a role in the pathophysiology and post-ventriculoperitoneal shunt gait improvement of INPH patients.

Sign in / Sign up

Export Citation Format

Share Document