NCT02212119

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Assistive Technology Clinic, Canada · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia
• Paratonia

Interventions

Type	Name	Description
DRUG	Botulinum Toxin
DRUG	Saline

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-02-01
• Completion: 2014-01-01
• First posted: 2014-08-08
• Last updated: 2014-08-08

Locations

1 site across 1 country: Canada