Trial reportPloS one2014
A randomized, placebo controlled pilot trial of botulinum toxin for paratonic rigidity in people with advanced cognitive impairment.
Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02212119 (A Randomized, Placebo Controlled Trial of Botulinum Toxin for Paratonic Rigidity in People With Advanced Cognitive Impairment), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Placebo Controlled Trial of Botulinum Toxin for Paratonic Rigidity in People With Advanced Cognitive Impairment
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.
- Paratonia in Dementia: A Systematic Review.Journal of Alzheimer's disease : JAD · 2020Pooled it
- Should Paratonia Be Considered a Movement Disorder? Implications for Clinical Management.Movement disorders clinical practice · 2026Article
- Paratonia in advanced dementia: Challenges and evidence-based interventions.Canadian family physician Medecin de famille canadien · 2026Article
- Botulinum Toxin Underuse in Older Stroke Survivors with Spasticity: A Nationwide Population-Based Cohort Study.Neuroepidemiology · 2025Article
- Efficacy and Safety of IncobotulinumtoxinA in Older Patients with Upper Limb Spasticity: A Pooled Analysis.Geriatrics (Basel, Switzerland) · 2025Article
- Treatment of Acquired Deforming Hypertonia with Botulinum Toxin in Older Population: A Retrospective Study.Toxins · 2024Article
- Does the regulation of skeletal muscle influence cognitive function? A scoping review of pre-clinical evidence.Journal of orthopaedic translation · 2023Article
- Electromyographic assessment of paratonia.Experimental brain research · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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 MEASURES: 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.
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.