Search: id:"swepub:oai:DiVA.org:umu-202116" >
Placebo-controlled ...
Placebo-controlled effectiveness of idiopathic normal pressure hydrocephalus shunting : a randomized pilot trial
-
- Luciano, Mark (author)
- Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
-
- Holubkov, Richard (author)
- 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
-
- Williams, Michael A. (author)
- 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
-
show more...
-
- Malm, Jan, Professor, 1957- (author)
- Umeå universitet,Neurovetenskaper
-
- Nagel, Sean (author)
- 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
-
- Moghekar, Abhay (author)
- 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
-
- Eklund, Anders, 1965- (author)
- Umeå universitet,Institutionen för strålningsvetenskaper
-
- Zwimpfer, Thomas (author)
- 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
-
- Katzen, Heather (author)
- 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
-
- Hanley, Daniel F. (author)
- Department of Neurology, Johns Hopkins University, Baltimore, Maryland, USA
-
- Hamilton, Mark G. (author)
- 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
-
show less...
-
(creator_code:org_t)
- 2022-11-25
- 2023
- English.
-
In: Neurosurgery. - : Wolters Kluwer. - 0148-396X .- 1524-4040. ; 92:3, s. 481-489
- Related links:
-
https://doi.org/10.1...
-
show more...
-
https://umu.diva-por... (primary) (Raw object)
-
https://urn.kb.se/re...
-
https://doi.org/10.1...
-
show less...
Abstract
Subject headings
Close
- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
Keyword
- NPH (normal pressure hydrocephalus)
- Hydrocephalus
- Shunting
- RCT
- Placebo
- VPS (ventriculoperitoneal shunting)
Publication and Content Type
- ref (subject category)
- art (subject category)
Find in a library
To the university's database
- By the author/editor
-
Luciano, Mark
-
Holubkov, Richar ...
-
Williams, Michae ...
-
Malm, Jan, Profe ...
-
Nagel, Sean
-
Moghekar, Abhay
-
show more...
-
Eklund, Anders, ...
-
Zwimpfer, Thomas
-
Katzen, Heather
-
Hanley, Daniel F ...
-
Hamilton, Mark G ...
-
show less...
- About the subject
-
- MEDICAL AND HEALTH SCIENCES
-
MEDICAL AND HEAL ...
-
and Clinical Medicin ...
-
and Neurology
- Articles in the publication
-
Neurosurgery
- By the university
-
Umeå University