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 Details — Status: Completed

Administrative data

• NCT number: NCT02212119
• Other study ID #: NT-036
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2014
• Last updated: August 7, 2014
• Start date: December 2010
• Est. completion date: January 2014

Study information

• Verified date: August 2014
• Source: Assistive Technology Clinic, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

• Dementia
• Paratonia

Intervention

Drug:
• Botulinum Toxin

• Saline

Locations

Country	Name	City	State
Canada	Assistive Technology Clinic at Baycrest	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Assistive Technology Clinic, Canada	Baycrest, Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Canada, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on care-giver burden	Impact on caregiver burden in providing upper extremity care.; Measured by the Carer Burden Scale which includes four items (cleaning the palm, cutting the fingernails, dressing, cleaning under the armpit).; Each item rated on five point Likert scale ("no difficulty" to "cannot do task").	6 weeks for primary outcome, 32 weeks for entire study	No
Secondary	Visual Analogue Scale	Completed by the professional caregiver that is caring for the patient to assess perception of ease of caregiving.; Consists of 100 mm line with anchors of 0 "giving care to the residents is very difficult" and 100 "giving care to the residents is very easy"	6 weeks for secondary outcome, 32 weeks for entire study	No
Secondary	Joint angle measurement	Joint angle measurements were used reflecting range of motion.; Used as a surrogate measure for severity of paratonia	6 weeks for secondary outcome, 32 weeks for entire study	No
Secondary	Pain	Pain Assessment in Advanced Dementia (PAINAD) Scale used to evaluate correlates of pain and determine whether Botulinum toxin treatment reduces discomfort of morning care.; Consists of 5 items (breathing, negative vocalization, facial expression, body language and consolability), scored on a 0-2 point scale and then summed to arrive at a total scale.	6 weeks for secondary outcome, 32 weeks for entire study	No
Secondary	Global Assessment	Overall response to treatment evaluated by study investigator and by professional caregiver caring for patient using the global assessment scale.; A score of -4 indicates very marked worsening, 0 no change, and +4 very marked improvement.	6 weeks for secondary outcome, 32 weeks for entire study	No