title: rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate.
abstract: OBJECTIVE
  This double-blind, randomized, placebo-controlled study investigated the impact of repetitive transcranial magnetic stimulation (rTMS) on quality of life (QoL) of patients with fibromyalgia, and its possible brain metabolic substrate.
  
  
  METHODS
  Thirty-eight patients were randomly assigned to receive high-frequency rTMS (n = 19) or sham stimulation (n = 19), applied to left primary motor cortex in 14 sessions over 10 weeks. Primary clinical outcomes were QoL changes at the end of week 11, measured using the Fibromyalgia Impact Questionnaire (FIQ). Secondary clinical outcomes were mental and physical QoL component measured using the 36-Item Short Form Health Survey (SF-36), but also pain, mood, and anxiety. Resting-state [(18)F]-fluorodeoxyglucose-PET metabolism was assessed at baseline, week 2, and week 11. Whole-brain voxel-based analysis was performed to study between-group metabolic changes over time.
  
  
  RESULTS
  At week 11, patients of the active rTMS group had greater QoL improvement in the FIQ (p = 0.032) and in the mental component of the SF-36 (p = 0.019) than the sham stimulation group. No significant impact was found for other clinical outcomes. Compared with the sham stimulation group, patients of the active rTMS group presented an increase in right medial temporal metabolism between baseline and week 11 (p < 0.001), which was correlated with FIQ and mental component SF-36 concomitant changes (r = -0.38, p = 0.043; r = 0.51, p = 0.009, respectively). QoL improvement involved mainly affective, emotional, and social dimensions.
  
  
  CONCLUSIONS
  Our study shows that rTMS improves QoL of patients with fibromyalgia. This improvement is associated with a concomitant increase in right limbic metabolism, arguing for a neural substrate to the impact of rTMS on emotional dimensions involved in QoL.
  
  
  METHODS
  This study provides Class II evidence that rTMS compared with sham rTMS improves QoL in patients with fibromyalgia.
authors.affiliation: From EA 3279-Self-perceived Health Assessment Research Unit (L.B.), School of Medicine, La Timone University, Marseille; Centre d'Evaluation et de Traitement de la Douleur (A. Dousset, P.R., N.D., V.P., A. Donnet) and Service Central de Biophysique et Médecine Nucléaire (S.C., O.M., E.G.), APHM, Hôpital de la Timone, Marseille; CERIMED (S.C., O.M., E.G.) and Institut de Neurosciences de la Timone, CNRS UMR 7289 (S.K., E.G.), Aix-Marseille Université, Marseille, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Boyer
authors.forename: Alix
authors.initials: A
authors.lastname: Dousset
authors.forename: Philippe
authors.initials: P
authors.lastname: Roussel
authors.forename: Nathalie
authors.initials: N
authors.lastname: Dossetto
authors.forename: Serge
authors.initials: S
authors.lastname: Cammilleri
authors.forename: Virginie
authors.initials: V
authors.lastname: Piano
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Khalfa
authors.forename: Olivier
authors.initials: O
authors.lastname: Mundler
authors.forename: Anne
authors.initials: A
authors.lastname: Donnet
authors.forename: Eric
authors.initials: E
authors.lastname: Guedj
mesh_terms: D000328:Adult; D000368:Aged; D001921:Brain / Q000378:metabolism* / Q000473:pathology; D001931:Brain Mapping / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000378:metabolism* / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D050781:Transcranial Magnetic Stimulation / Q000379:methods; D016896:Treatment Outcome