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

Published online by Cambridge University Press:  05 January 2022

MG Hamilton
Affiliation:
(Calgary)*
M Williams
Affiliation:
(Seattle)
R Holubkov
Affiliation:
(Salt Lake City)
S Nagel
Affiliation:
(Cleveland)
J Wisoff
Affiliation:
(New York)
G McKhann
Affiliation:
(New York)
T Zwimpfer
Affiliation:
(Vancouver)
R Edwards
Affiliation:
(Bristol)
J Malm
Affiliation:
(Umea)
A Moghekar
Affiliation:
(Baltimore)
A Eklund
Affiliation:
(Umea)
J Golomb
Affiliation:
(New York)
H Katzen
Affiliation:
(Miami)
N Dasher
Affiliation:
(Seattle)
M Luciano
Affiliation:
(Baltimore)
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Abstract

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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.

Type
Poster Presentations
Copyright
© The Author(s), 2021. Published by Cambridge University Press on behalf of Canadian Neurological Sciences Federation
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P.208 Pilot Study of a Multi-center, Randomized, Blinded, Placebo-Controlled Trial of Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus
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P.208 Pilot Study of a Multi-center, Randomized, Blinded, Placebo-Controlled Trial of Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus
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P.208 Pilot Study of a Multi-center, Randomized, Blinded, Placebo-Controlled Trial of Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus
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