title: A double-blind randomized trial on the clinical effect of different shunt valve settings in idiopathic normal pressure hydrocephalus.
abstract: OBJECTIVE
  The study aim was to examine the effect of gradually reducing the opening pressure on symptoms and signs in the shunt treatment of idiopathic normal pressure hydrocephalus (iNPH).
  
  
  METHODS
  In this prospective double-blinded, randomized, controlled, double-center study on patients with iNPH, a ventriculoperitoneal shunt with an adjustable Codman Medos Valve was implanted in 68 patients randomized into 2 groups. In 1 group (the 20-4 group) the valve setting was initially set to 20 cm H2O and gradually reduced to 4 cm H2O over the course of the 6-month study period. In the other group (the 12 group), the valve was kept at a medium level of 12 cm H2O during the whole study period. All patients were clinically evaluated using 4 tests preoperatively as well as postoperatively at 1, 2, 3, 4, and 6 months. The test scores between the 2 groups (20-4 and 12) were compared for each clinical evaluation.
  
  
  RESULTS
  Fifty-five patients (81%) were able to complete the study. There were no significant differences between the 2 groups (20-4 and 12) preoperatively or at any time postoperatively. Both groups exhibited significant clinical improvement after shunt insertion at all valve settings compared with the preoperative score, with the greatest improvement observed at the first postoperative evaluation. The clinical improvement was significant within the first 3 months, and thereafter no significant improvement was seen in either group.
  
  
  CONCLUSIONS
  Gradual reduction of the valve setting from 20 to 4 cm H2O did not improve outcome compared with a fixed valve setting of 12 cm H2O. Improvement after shunt surgery in iNPH patients was evident within 3 months, irrespective of valve setting.
authors: Hydrocephalus Research Unit, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; and.
authors: Dan
authors: D
authors: Farahmand
authors: Department of Neurosurgery and.
authors: Terje
authors: T
authors: Sæhle
authors: Department of Neurosurgery and.|Faculty of Medicine, Oslo University Hospital, Oslo, Norway.
authors: Per Kristian
authors: PK
authors: Eide
authors: Hydrocephalus Research Unit, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; and.
authors: Magnus
authors: M
authors: Tisell
authors: Hydrocephalus Research Unit, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; and.
authors: Per
authors: P
authors: Hellström
authors: Hydrocephalus Research Unit, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; and.
authors: Carsten
authors: C
authors: Wikkelsö
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006850:Hydrocephalus, Normal Pressure / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D019635:Neurosurgical Procedures / Q000379:methods; D011312:Pressure; D011446:Prospective Studies; D016896:Treatment Outcome; D017287:Ventriculoperitoneal Shunt / Q000379:methods* / Q000592:standards; D016138:Walking
keywords: ASD = antisiphon device; BMI = body mass index; ICP = intracranial pressure; ITT = intention-to-treat; RCT = randomized controlled trial; SDH = subdural hematoma; SDS = standard deviation score (standardized score); VA = ventriculoatrial; VP = ventriculoperitoneal; adjustable valve; clinical effect; hydrocephalus; iNPH = idiopathic normal pressure hydrocephalus; idiopathic normal pressure hydrocephalus; opening pressure; randomized controlled trial; shunt surgery; tSDS = total SDS