Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
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.