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Abstract Details

Pilot Study of a Randomized, Blinded, Placebo-Controlled Trial of Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus
Aging, Dementia, and Behavioral Neurology
Aging and Dementia Posters (7:00 AM-5:00 PM)
011

To describe the preliminary results of a pilot randomized, blinded, placebo-controlled trial of shunt surgery in idiopathic normal pressure hydrocephalus (iNPH).

iNPH was first described in 1965. While multiple prospective non-randomized studies have shown that 60-70% of patients improve with shunt surgery, no multi-center placebo-controlled trial has been performed.
The Adult Hydrocephalus Clinical Research Network conducted the study. Patients receiving shunt surgery (Codman® Certas® Plus with SiphonGuard®) based on response to CSF drainage were randomized to either valve opening pressure 110 mm H2O (Active Group) or “virtual off” valve opening pressure >400 mm H2O (Placebo Group) shunt settings. Patients and assessors were blinded to the shunt setting. 4-month outcomes included 10-meter gait velocity (primary efficacy outcome), Montreal Cognitive Assessment (MoCA), Symbol Digit Modalities Test (SDMT), Beck Depression Inventory (BDI-II), Lawton ADL/IADL Questionnaire, Modified Rankin Scale (mRS), and Overactive Bladder Questionnaire, short form (OAB-q).  After the 4-month assessment, all shunts were adjusted using a noninvasive technique that preserved blinding, with the Placebo Group changed to an active setting and the Active Group setting maintained. 

9 subjects were enrolled in each group. At the 4-month primary evaluation, gait velocity increased by 0.28 ± 0.28 m/s in the Active Group and 0.06 ± 0.15 m/s in the Placebo Group (p=0.078), a treatment difference of 0.21 m/s (95% CI:  -0.03, 0.45). OAB-q significantly improved in Active versus Placebo (p=0.007). No significant between-group differences were found for the MoCA, SDMT, BDI-II, Lawton ADL/IADL, or mRS. The 8- and 12-month evaluations are ongoing.

This multi-center, randomized, blinded, placebo-controlled pilot study (n=18) suggests that shunt surgery for iNPH may improve gait velocity more with an active shunt setting than a placebo setting, although the treatment difference was not statistically significant. A larger, sufficiently powered trial is indicated to confirm this efficacy finding.

Authors/Disclosures
Michael A. Williams, MD, FÂ鶹´«Ã½Ó³»­ (University of Washington School of Medicine)
PRESENTER 		Dr. Williams has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for the Hydrocephalus Association, a not-for-profit patient advocacay organization. The institution of Dr. Williams has received research support from NASA. The institution of Dr. Williams has received research support from Translational Research Insitute for Space Health (TRISH). The institution of Dr. Williams has received research support from NINDS.
Jan Malm, PhD (Umeå Universtiy) No disclosure on file
Abhay Moghekar, MD (Johns Hopkins Bayview Medical Center) Dr. Moghekar has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Deluca and Weizenbaum. Dr. Moghekar has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Silver Golub and Tieteel. The institution of Dr. Moghekar has received research support from NIH. Dr. Moghekar has a non-compensated relationship as a Medical Advisory Board member with Hydrocephalus Association that is relevant to Â鶹´«Ã½Ó³»­ interests or activities. Dr. Moghekar has a non-compensated relationship as a Medical Advisory Board member with Spinal CSF Leak Foundation that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
No disclosure on file
Heather Katzen, PhD Dr. Katzen has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Adult Hydrocephalus Clinical Research Network. Dr. Katzen has received publishing royalties from a publication relating to health care.
No disclosure on file
No disclosure on file
No disclosure on file
Mark Hamilton, MD (Foothills Hospital, Dept of Neurosurgery) Dr. Hamilton has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Integra International. Dr. Hamilton has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer Nature. The institution of Dr. Hamilton has received research support from Hydrocephalus Association. The institution of Dr. Hamilton has received research support from NIH. The institution of Dr. Hamilton has received research support from Alberta Innovates.
Mark Luciano, MD, PhD (Cleveland Clinic) No disclosure on file