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  • Luciano, MarkDepartment of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA (author)

Placebo-controlled effectiveness of idiopathic normal pressure hydrocephalus shunting : a randomized pilot trial

  • Article/chapterEnglish2023

Publisher, publication year, extent ...

  • 2022-11-25
  • Wolters Kluwer,2023
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:umu-202116
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-202116URI
  • https://doi.org/10.1227/neu.0000000000002225DOI

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  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • 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.

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Added entries (persons, corporate bodies, meetings, titles ...)

  • Holubkov, RichardAdult Hydrocephalus Clinical Research Network, Department of Pediatrics, Division of Critical Care, University of Utah School of Medicine, Salt Lake City, Utah, USA; Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA (author)
  • Williams, Michael A.Adult Hydrocephalus Clinical Research Network, Department of Pediatrics, Division of Critical Care, University of Utah School of Medicine, Salt Lake City, Utah, USA; Departments of Neurology and Neurological Surgery, University of Washington School of Medicine, Seattle, Washington, USA (author)
  • Malm, Jan,Professor,1957-Umeå universitet,Neurovetenskaper(Swepub:umu)jama0002 (author)
  • Nagel, SeanAdult Hydrocephalus Clinical Research Network, Department of Pediatrics, Division of Critical Care, University of Utah School of Medicine, Salt Lake City, Utah, USA; Center for Neurological Restoration, Cleveland Clinic, Cleveland, Ohio, USA; Department of Neurosurgery, Cleveland Clinic, Cleveland, Ohio, USA (author)
  • Moghekar, AbhayAdult Hydrocephalus Clinical Research Network, Department of Pediatrics, Division of Critical Care, University of Utah School of Medicine, Salt Lake City, Utah, USA; Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA (author)
  • Eklund, Anders,1965-Umeå universitet,Institutionen för strålningsvetenskaper(Swepub:umu)anek0025 (author)
  • Zwimpfer, ThomasAdult Hydrocephalus Clinical Research Network, Department of Pediatrics, Division of Critical Care, University of Utah School of Medicine, Salt Lake City, Utah, USA; Division of Neurosurgery, Department of Surgery, University of British Columbia, Vancouver, Canada (author)
  • Katzen, HeatherAdult Hydrocephalus Clinical Research Network, Department of Pediatrics, Division of Critical Care, University of Utah School of Medicine, Salt Lake City, Utah, USA; Department of Neurology, University of Miami Miller School of Medicine, Miami, Florida, USA (author)
  • Hanley, Daniel F.Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA (author)
  • Hamilton, Mark G.Adult Hydrocephalus Clinical Research Network, Department of Pediatrics, Division of Critical Care, University of Utah School of Medicine, Salt Lake City, Utah, USA; Division of Neurosurgery, Department of Clinical Neurosciences, Cumming School of Medicine, University of Calgary, Calgary, Canada (author)
  • Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USAAdult Hydrocephalus Clinical Research Network, Department of Pediatrics, Division of Critical Care, University of Utah School of Medicine, Salt Lake City, Utah, USA; Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, Utah, USA (creator_code:org_t)

Related titles

  • In:Neurosurgery: Wolters Kluwer92:3, s. 481-4890148-396X1524-4040

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