title: A randomized, placebo controlled pilot trial of botulinum toxin for paratonic rigidity in people with advanced cognitive impairment.
abstract: OBJECTIVE
  Evaluate safety and efficacy of Incobotulinumtoxin A in elderly patients with dementia and paratonia.
  
  
  METHODS
  University-affiliated hospital, spasticity management Clinic.
  
  
  METHODS
  Ten subjects were enrolled.
  
  
  METHODS
  1) severe cognitive impairment 2) diagnosis of Alzheimer's disease, vascular dementia, or frontotemporal dementia, and 3) score >3 on the paratonic assessment instrument, with posture in an arm(s) interfering with provision of care.
  
  
  METHODS
  1) alternate etiologies for increased tone and 2) injection with botulinum toxin within the 6 months preceding the study.
  
  
  METHODS
  Single center, randomized, double blind, placebo-controlled, crossover trial with two treatment cycles of 16 weeks. Assessments occurred at 2, 6, 12 and16 weeks following injections. Subjects received up to 300 U of Incobotulinumtoxin A in arm(s).
  
  
  METHODS
  Primary outcome measure was the modified caregiver burden scale (mCBS); exploratory secondary outcome measures were also performed. Analysis of variance and mixed modeling techniques were used to evaluate treatment effects.
  
  
  RESULTS
  Incobotulinumtoxin A treatment produced significant improvement in mCBS total score -1.11 (-2.04 to -0.18) (Treatment effect and 95% CI), dressing sub-score -0.36 (-0.59 to 0.12), and cleaning under the left and right armpits sub-score -0.5 (-0.96 to -0.04), -0.41 (-0.79 to -0.04) respectively. PROM in the left and right elbow increased by 27.67 degrees (13.32-42.02) and 22.07 degrees (9.76-34.39) respectively. PROM in the left and right shoulder increased by 11.92 degrees (5.46-18.38) and 8.58 degrees (3.73-13.43) respectively. No significant treatment effect was found for GAS, VAS and PAINAD scales or change in time to perform care. No adverse drug reactions occurred.
  
  
  CONCLUSIONS
  Administration of Incobotulinumtoxin A in elderly people with advanced dementia and paratonia may be an efficacious and safe treatment to increase range of motion and reduce functional burden. Further studies are needed to confirm results.
  
  
  BACKGROUND
  ClinicalTrials.Gov NCT02212119.
authors.affiliation: Jeff and Diane Ross Movement Disorders Clinic, Assistive Technology Clinic, Toronto, Canada; Baycrest Center for Geriatric Health, University of Toronto, Toronto, Canada; Department of Medicine, Division of Neurology, University of Toronto, Toronto, Canada.
authors.forename: Galit
authors.initials: G
authors.lastname: Kleiner-Fisman
authors.affiliation: Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
authors.forename: Edwin
authors.initials: E
authors.lastname: Khoo
authors.affiliation: Jeff and Diane Ross Movement Disorders Clinic, Assistive Technology Clinic, Toronto, Canada.
authors.forename: Nikohl
authors.initials: N
authors.lastname: Moncrieffe
authors.affiliation: Jeff and Diane Ross Movement Disorders Clinic, Assistive Technology Clinic, Toronto, Canada.
authors.forename: Triina
authors.initials: T
authors.lastname: Forbell
authors.affiliation: Jeff and Diane Ross Movement Disorders Clinic, Assistive Technology Clinic, Toronto, Canada.
authors.forename: Pearl
authors.initials: P
authors.lastname: Gryfe
authors.affiliation: Dalla Lana School of Public Health, University of Toronto, Toronto, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Fisman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D003072:Cognition Disorders / Q000150:complications* / Q000188:drug therapy*; D003710:Demography; D005260:Female; D006801:Humans; D008297:Male; D008954:Models, Biological; D009127:Muscle Rigidity / Q000150:complications* / Q000188:drug therapy*; D010865:Pilot Projects; D010919:Placebos; D016059:Range of Motion, Articular / Q000187:drug effects; D015203:Reproducibility of Results; D064232:Visual Analog Scale
chemical_list: D010919:Placebos; D019274:Botulinum Toxins, Type A; C545476:incobotulinumtoxinA