Placebo-Controlled Effectiveness of Idiopathic Normal Pressure Hydrocephalus Shunting: A Randomized Pilot Trial. Issue 3 (25th March 2023)

• Record Type: Journal Article
• Authors: Luciano, Mark; Holubkov, Richard; Williams, Michael A.; Malm, Jan; Nagel, Sean; Moghekar, Abhay; Eklund, Anders; Zwimpfer, Thomas; Katzen, Heather; Hanley, Daniel F.; Hamilton, Mark G.
• Other Names: Meggyesy Michael author non-byline.; Yasar Sevil author non-byline.; Gulyani Seema author non-byline.; Koskinen Lars-Owe D. author non-byline.; Hansson William author non-byline.; Cecchini Michelle author non-byline.; Dasher Nickolas author non-byline.; Bain Mark author non-byline.; Wisoff Jeffrey author non-byline.; McKhann Guy author non-byline.; Edwards Richard author non-byline.; Golomb James author non-byline.; Zuspan SallyJo author non-byline.; Jones Cynthia author non-byline.; Marron Brie author non-byline.; Bracken Caleb author non-byline.; Jensen Hailey author non-byline.; Wollett Jessica author non-byline.; Smith Lynn author non-byline.; Haynes Cindy author non-byline.; Darrow Jackie author non-byline.; Dirmeyer Kallan author non-byline.; Economas Tracey author non-byline.; Ritter Cristina author non-byline.; Hedges Jennell author non-byline.; Manthripragada Lacie author non-byline.; Larsson Jenny author non-byline.; Nyman Kristin author non-byline.; McGee Elisa author non-byline.; Anderson Amy author non-byline.; Tecle Agazit author non-byline.; Hennigs Erica author non-byline.; Koepsel Mandi author non-byline.; Rabana Marcia Leon author non-byline.; Kheniser Karim author non-byline.; Dronyk Jarred author non-byline.; Urbaneja Geberth author non-byline.;
• Is Part Of: Neurosurgery. Volume 92:Issue 3(2023)
• Page Start: 481
• Page End: 489
• Publication Date: 2023-03-25
• Subjects: NPH (normal pressure hydrocephalus) -- Hydrocephalus -- Shunting -- RCT -- Placebo -- VPS (ventriculoperitoneal shunting); Nervous system -- Surgery -- Periodicals; 617.48005
• DOI: 10.1227/neu.0000000000002225
• Languages: English
• ISSNs: 0148-396X

Abstract

Abstract : BACKGROUND: Multiple prospective nonrandomized studies have shown 60% to 70% of patients with idiopathic normal pressure hydrocephalus (iNPH) improve with shunt surgery, but multicenter placebo-controlled trial data are necessary to determine its effectiveness. OBJECTIVE: To evaluate the effectiveness of cerebrospinal fluid shunting in iNPH through comparison of open vs placebo shunting groups at 4 months using a pilot study. METHODS: Patients were randomized to a Codman Certas Plus valve (Integra LifeSciences) set at 4 (open shunt group) or 8 ("virtual off"; placebo group). Patients and assessors were blinded to treatment group. The primary outcome measure was 10-m gait velocity. Secondary outcome measures included functional scales for bladder control, activities of daily living, depression, and quality of life. Immediately after 4-month evaluation, all shunts were adjusted in a blinded fashion to an active setting and followed to 12 months after shunting. RESULTS: A total of 18 patients were randomized. At the 4-month evaluation, gait velocity increased by 0.28 ± 0.28 m/s in the open shunt group vs 0.04 ± 0.17 m/s in the placebo group. The estimated treatment difference was 0.22 m/s ([ P = .071], 95% CI −0.02 to 0.46). Overactive Bladder Short Form symptom bother questionnaire significantly improved in open shunt vs placebo ( P = .007). The 4-month treatment delay did not reduce the subsequent response to active shunting, nor did it increase the adverse advents rate at 12 months. CONCLUSION: This multicenter, randomized pilot study demonstrates the effectiveness, safety, and feasibility of a placebo-controlled trial in iNPH, and found a trend suggesting gait velocity improves more in the open shunt group than in the placebo group.