Abstract
ObjectiveEvaluate safety and efficacy of Incobotulinumtoxin A in elderly patients with dementia and paratonia.SettingUniversity-affiliated hospital, spasticity management Clinic.ParticipantsTen subjects were enrolled. Inclusion criteria: 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. Exclusion criteria: 1) alternate etiologies for increased tone and 2) injection with botulinum toxin within the 6 months preceding the study.DesignSingle 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).Primary and Secondary Outcome MeasuresPrimary 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.ResultsIncobotulinumtoxin 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.ConclusionsAdministration 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.Trial RegistrationClinicalTrials.Gov NCT02212119
Highlights
It is frequently assumed that dementia is a disorder only of cognitive impairment; dementia is often accompanied by significant motor disability due in part to ‘‘paratonia’’, a form of increased muscle tone
The study began in January 2011 and ended in March 2013
This study represents the first clinical randomized, double blind, placebo-controlled trial of Botulinum toxin administration for paratonic rigidity in persons with dementia; we believe this is the first clinical trial of any type for this indication. Though this is a small pilot study, the results suggest that in elderly, dependent, cognitively impaired individuals with increased muscle tone due to paratonia, Incobotulinumtoxin A is an intervention that provides meaningful reduction in caregiver burden
Summary
It is frequently assumed that dementia is a disorder only of cognitive impairment; dementia is often accompanied by significant motor disability due in part to ‘‘paratonia’’, a form of increased muscle tone. Paratonia has been estimated to be present in 5% of those with mild cognitive impairments and 100% in those with advanced dementia [2,3,4,5]. Postulated to originate in the central nervous system, paratonia exerts its effects by increasing muscle resistance reflexively when a limb is moved passively (though can fluctuate in severity depending on level of relaxation of the person). Paratonia may exist at rest with constant muscle contraction leading to fixed postures (contractures). Some of the consequences of paratonia and fixed postures include difficulties in washing, dressing, feeding, and providing general care, to a fully dependent person increasing caregiver burden. Fixed postures may lead to skin breakdown, infection, and pain upon movement, thereby reducing comfort and quality of life
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