Clinical trial NCT02212119: Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness
Official title: A Randomized, Placebo Controlled Trial of Botulinum Toxin for Paratonic Rigidity in People With Advanced Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia
Paratonia
Keywords: Dementia
Paratonia
Caregiver Burden
Botulinum toxin
Lead sponsor: Assistive Technology Clinic, Canada
Sponsor class: OTHER
Collaborators: name: Merz Pharmaceuticals GmbH
name: Baycrest
First posted: 2014-08-08
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Severe cognitive impairment (complete dependency in all activities of daily living (ADLs)
* Diagnosis of Alzheimer's disease, vascular dementia,or frontotemporal dementia
* Score\> 3 on the paratonic assessment instrument, with paratonic rigidity in an arm(s) interfering in the provision of care

Exclusion Criteria:

* Alternate etiologies for increased tone
* Botulinum toxin 6 months preceding the study

Primary outcomes:
measure: Impact on care-giver burden
timeFrame: 6 weeks for primary outcome, 32 weeks for entire study
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 6 weeks for secondary outcome, 32 weeks for entire study
measure: Joint angle measurement
timeFrame: 6 weeks for secondary outcome, 32 weeks for entire study
measure: Pain
timeFrame: 6 weeks for secondary outcome, 32 weeks for entire study
measure: Global Assessment
timeFrame: 6 weeks for secondary outcome, 32 weeks for entire study
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Assistive Technology Clinic at Baycrest
state: Ontario
Study officials:
affiliation: University of Toronto, Baycrest
name: Galit Kleiner-Fisman, MD
role: PRINCIPAL_INVESTIGATOR
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