title: Transcutaneous noninvasive vagus nerve stimulation (tVNS) in the treatment of schizophrenia: a bicentric randomized controlled pilot study.
abstract: Despite many pharmacological and psychosocial treatment options, schizophrenia remains a debilitating disorder. Thus, new treatment strategies rooted in the pathophysiology of the disorder are needed. Recently, vagus nerve stimulation (VNS) has been proposed as a potential treatment option for various neuropsychiatric disorders including schizophrenia. The objective of this study was to investigate for the first time the feasibility, safety and efficacy of transcutaneous VNS in stable schizophrenia. A bicentric randomized, sham-controlled, double-blind trial was conducted from 2010 to 2012. Twenty schizophrenia patients were randomly assigned to one of two treatment groups. The first group (active tVNS) received daily active stimulation of the left auricle for 26 weeks. The second group (sham tVNS) received daily sham stimulation for 12 weeks followed by 14 weeks of active stimulation. Primary outcome was defined as change in the Positive and Negative Symptom Scale total score between baseline and week 12. Various other secondary measures were assessed to investigate safety and efficacy. The intervention was well tolerated with no relevant adverse effects. We could not observe a statistically significant difference in the improvement of schizophrenia psychopathology during the observation period. Neither psychopathological and neurocognitive measures nor safety measures showed significant differences between study groups. Application of tVNS was well tolerated, but did not improve schizophrenia symptoms in our 26-week trial. While unsatisfactory compliance questions the feasibility of patient-controlled neurostimulation in schizophrenia, the overall pattern of symptom change might warrant further investigations in this population.
authors.affiliation: Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University (LMU) Munich, Nussbaumstr. 7, 80336, Munich, Germany. Alkomiet.Hasan@med.uni-muenchen.de.
authors.forename: Alkomiet
authors.initials: A
authors.lastname: Hasan
authors.affiliation: Department of Psychiatry and Psychotherapy, Georg-August-University Göttingen, Göttingen, Germany.
authors.forename: Claus
authors.initials: C
authors.lastname: Wolff-Menzler
authors.affiliation: Institut für anwendungsorientierte Forschung und klinische Studien GmbH, Göttingen, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Pfeiffer
authors.affiliation: Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University (LMU) Munich, Nussbaumstr. 7, 80336, Munich, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Falkai
authors.affiliation: Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University (LMU) Munich, Nussbaumstr. 7, 80336, Munich, Germany.
authors.forename: Elif
authors.initials: E
authors.lastname: Weidinger
authors.affiliation: Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University (LMU) Munich, Nussbaumstr. 7, 80336, Munich, Germany.
authors.forename: Andrea
authors.initials: A
authors.lastname: Jobst
authors.affiliation: Department of Psychiatry and Psychotherapy, Georg-August-University Göttingen, Göttingen, Germany.
authors.forename: Imke
authors.initials: I
authors.lastname: Hoell
authors.affiliation: Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University (LMU) Munich, Nussbaumstr. 7, 80336, Munich, Germany.
authors.forename: Berend
authors.initials: B
authors.lastname: Malchow
authors.affiliation: Department of Psychiatry and Psychotherapy, Georg-August-University Göttingen, Göttingen, Germany.
authors.forename: Peyman
authors.initials: P
authors.lastname: Yeganeh-Doost
authors.affiliation: Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University (LMU) Munich, Nussbaumstr. 7, 80336, Munich, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Strube
authors.affiliation: Department of Psychiatry and Psychotherapy, Georg-August-University Göttingen, Göttingen, Germany.
authors.forename: Silke
authors.initials: S
authors.lastname: Quast
authors.affiliation: Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-University (LMU) Munich, Nussbaumstr. 7, 80336, Munich, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Müller
authors.affiliation: Department of Psychiatry and Psychotherapy, Georg-August-University Göttingen, Göttingen, Germany.|Centre of Mental Health, Darmstadt-Dieburg Clinics, Groß-Umstadt, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Wobrock
mesh_terms: D000328:Adult; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012559:Schizophrenia / Q000628:therapy*; D012565:Schizophrenic Psychology; D004561:Transcutaneous Electric Nerve Stimulation / Q000379:methods*; D016896:Treatment Outcome; D055536:Vagus Nerve Stimulation / Q000379:methods*; D055815:Young Adult
keywords: Noninvasive brain stimulation; Patient-controlled neurostimulation; Schizophrenia; Vagus nerve; tVNS