Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness
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|ClinicalTrials.gov Identifier: NCT02212119|
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Dementia Paratonia||Drug: Botulinum Toxin Drug: Saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Placebo Controlled Trial of Botulinum Toxin for Paratonic Rigidity in People With Advanced Cognitive Impairment|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||January 2014|
Placebo Comparator: Saline
Saline injection up to 5 cc in arm with paratonia (one time injection)
Active Comparator: Botulinum Toxin
Up to 300 U (5 cc) of Botulinum toxin diluted 2:1 (2 cc per 100 U of Botulinum toxin) (one time injection)
Drug: Botulinum Toxin
Other Name: Xeomin
- Impact on care-giver burden [ Time Frame: 6 weeks for primary outcome, 32 weeks for entire study ]
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").
- Visual Analogue Scale [ Time Frame: 6 weeks for secondary outcome, 32 weeks for entire study ]
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"
- Joint angle measurement [ Time Frame: 6 weeks for secondary outcome, 32 weeks for entire study ]
Joint angle measurements were used reflecting range of motion.
Used as a surrogate measure for severity of paratonia
- Pain [ Time Frame: 6 weeks for secondary outcome, 32 weeks for entire study ]
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.
- Global Assessment [ Time Frame: 6 weeks for secondary outcome, 32 weeks for entire study ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212119
|Assistive Technology Clinic at Baycrest|
|Toronto, Ontario, Canada, M6A 2E1|
|Principal Investigator:||Galit Kleiner-Fisman, MD||University of Toronto, Baycrest|