Status:
COMPLETED
Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness
Lead Sponsor:
Assistive Technology Clinic, Canada
Collaborating Sponsors:
Merz Pharmaceuticals GmbH
Baycrest
Conditions:
Dementia
Paratonia
Eligibility:
All Genders
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- Alternate etiologies for increased tone
- Botulinum toxin 6 months preceding the study
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02212119
Start Date
December 1 2010
End Date
January 1 2014
Last Update
August 8 2014
Active Locations (1)
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1
Assistive Technology Clinic at Baycrest
Toronto, Ontario, Canada, M6A 2E1