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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02212119
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Merz Pharmaceuticals GmbH
Information provided by (Responsible Party):
Dr. Galit Kleiner-Fisman, Assistive Technology Clinic, Canada

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.

Condition or disease Intervention/treatment Phase
Dementia Paratonia Drug: Botulinum Toxin Drug: Saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Placebo Comparator: Saline
Saline injection up to 5 cc in arm with paratonia (one time injection)
Drug: Saline
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

Primary Outcome Measures :
  1. 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").

Secondary Outcome Measures :
  1. 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"

  2. 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

  3. 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.

  4. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02212119

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Canada, Ontario
Assistive Technology Clinic at Baycrest
Toronto, Ontario, Canada, M6A 2E1
Sponsors and Collaborators
Assistive Technology Clinic, Canada
Merz Pharmaceuticals GmbH
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Principal Investigator: Galit Kleiner-Fisman, MD University of Toronto, Baycrest

Smetanin P, Kobak P, Briante C, Ahmad S. Rising Tide: The Impact of Dementia in Canada 2008 to 2038. RiskAnalytica; 2009.
Knapp M, Comas-Herrera, Somani A, Banerjee S. Dementia: Summary report for the National Audit Office international comparisons. London: Personal Social Services Research Unit London School of Economics and Political Science and Section of Mental Health and Ageing The Institute of Psychiatry, King's College London; 2007.
Dupre E. Debilite mentale and debilite motrice associees. Rev Neurol 1910;20:54-56.
Delagi EF, Perotto A, Iazzetti J, Morrison D. Anatomic Guides for the Elecromyographer. In: Charles C.Thomas, ed., 2nd ed Springfield, 1980.
Bhakta BB, Tennant A, Cozens JA, et al. Application of item response theory to measure the disabling effects of severe upper limb spasticity in stroke and the consequent carer burden. Cerebrovascular Dis 1999;9:124.
Waltz CFSOL, Lenz ER. Measurement in Nursing Research, 2nd ed. Philadelphia: F.A. Davis, 1991.
Waardenburg H, Elvers W, Van Vechgel F, Oostendorp R. Can paratonia be measured reliably? Evaluation of the reliability of a visual analogue scale and the modified tonus sclae of Ashworth for measuring paratonia. Nederlands Tijdschrift voor Fysiotherapie (in dutch) 1999;102:30-35.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. Galit Kleiner-Fisman, Medical Director, Assistive Technology Clinic, Assistant Professor Department of Medicine, University of Toronto, Assistive Technology Clinic, Canada Identifier: NCT02212119    
Other Study ID Numbers: NT-036
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Keywords provided by Dr. Galit Kleiner-Fisman, Assistive Technology Clinic, Canada:
Caregiver Burden
Botulinum toxin
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs