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Placebo-controlled ...
Placebo-controlled effectiveness of idiopathic normal pressure hydrocephalus shunting : a randomized pilot trial
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- Luciano, Mark (författare)
- Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
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- Holubkov, Richard (författare)
- Adult 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
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- Williams, Michael A. (författare)
- 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
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- Malm, Jan, Professor, 1957- (författare)
- Umeå universitet,Neurovetenskaper
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- Nagel, Sean (författare)
- Adult 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
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- Moghekar, Abhay (författare)
- Adult 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
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- Eklund, Anders, 1965- (författare)
- Umeå universitet,Institutionen för strålningsvetenskaper
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- Zwimpfer, Thomas (författare)
- 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 Surgery, University of British Columbia, Vancouver, Canada
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- Katzen, Heather (författare)
- Adult 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
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- Hanley, Daniel F. (författare)
- Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA
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- Hamilton, Mark G. (författare)
- 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
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(creator_code:org_t)
- 2022-11-25
- 2023
- Engelska.
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Ingår i: Neurosurgery. - : Wolters Kluwer. - 0148-396X .- 1524-4040. ; 92:3, s. 481-489
- Relaterad länk:
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https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
Nyckelord
- NPH (normal pressure hydrocephalus)
- Hydrocephalus
- Shunting
- RCT
- Placebo
- VPS (ventriculoperitoneal shunting)
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- ref (ämneskategori)
- art (ämneskategori)
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Luciano, Mark
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Holubkov, Richar ...
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Williams, Michae ...
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Malm, Jan, Profe ...
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Nagel, Sean
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Moghekar, Abhay
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Eklund, Anders, ...
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Zwimpfer, Thomas
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Katzen, Heather
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Hanley, Daniel F ...
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Hamilton, Mark G ...
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- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Neurologi
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Neurosurgery
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Umeå universitet