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Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness

Dementia Clinical Trial

Official title:
A Randomized, Placebo Controlled Trial of Botulinum Toxin for Paratonic Rigidity in People With Advanced Cognitive Impairment

Clinical Trial Summary

Aim of the study is to perform a pilot study to assess the impact of Botulinum toxin on muscle tone, and caregiver burden in individuals who are cognitively impaired and who are fully dependent.

The primary objective is to confirm proof of principle that paratonic rigidity and the consequences associated with it can be reduced with injection of Botulinum toxin injections resulting in reduced care-giver burden.

The secondary objectives are to determine optimal time points for evaluation of efficacy in this patient population and whether the time period is sufficient for washout of Botulinum toxin effect; determine most salient and sensitive outcome measures; identify obstacles in data gathering; and lastly, to determine feasibility of battery of assessments in this pilot study.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02212119
Study type Interventional
Source Assistive Technology Clinic, Canada
Contact
Status Completed
Phase Phase 2
Start date December 2010
Completion date January 2014
View Details
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