<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02212119</url>
  </required_header>
  <id_info>
    <org_study_id>NT-036</org_study_id>
    <nct_id>NCT02212119</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness</brief_title>
  <official_title>A Randomized, Placebo Controlled Trial of Botulinum Toxin for Paratonic Rigidity in People With Advanced Cognitive Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistive Technology Clinic, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merz Pharmaceuticals GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baycrest</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistive Technology Clinic, Canada</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study is to perform a pilot study to assess the impact of Botulinum toxin on&#xD;
      muscle tone, and caregiver burden in individuals who are cognitively impaired and who are&#xD;
      fully dependent.&#xD;
&#xD;
      The primary objective is to confirm proof of principle that paratonic rigidity and the&#xD;
      consequences associated with it can be reduced with injection of Botulinum toxin injections&#xD;
      resulting in reduced care-giver burden.&#xD;
&#xD;
      The secondary objectives are to determine optimal time points for evaluation of efficacy in&#xD;
      this patient population and whether the time period is sufficient for washout of Botulinum&#xD;
      toxin effect; determine most salient and sensitive outcome measures; identify obstacles in&#xD;
      data gathering; and lastly, to determine feasibility of battery of assessments in this pilot&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact on care-giver burden</measure>
    <time_frame>6 weeks for primary outcome, 32 weeks for entire study</time_frame>
    <description>Impact on caregiver burden in providing upper extremity care.&#xD;
Measured by the Carer Burden Scale which includes four items (cleaning the palm, cutting the fingernails, dressing, cleaning under the armpit).&#xD;
Each item rated on five point Likert scale (&quot;no difficulty&quot; to &quot;cannot do task&quot;).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>6 weeks for secondary outcome, 32 weeks for entire study</time_frame>
    <description>Completed by the professional caregiver that is caring for the patient to assess perception of ease of caregiving.&#xD;
Consists of 100 mm line with anchors of 0 &quot;giving care to the residents is very difficult&quot; and 100 &quot;giving care to the residents is very easy&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint angle measurement</measure>
    <time_frame>6 weeks for secondary outcome, 32 weeks for entire study</time_frame>
    <description>Joint angle measurements were used reflecting range of motion.&#xD;
Used as a surrogate measure for severity of paratonia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>6 weeks for secondary outcome, 32 weeks for entire study</time_frame>
    <description>Pain Assessment in Advanced Dementia (PAINAD) Scale used to evaluate correlates of pain and determine whether Botulinum toxin treatment reduces discomfort of morning care.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment</measure>
    <time_frame>6 weeks for secondary outcome, 32 weeks for entire study</time_frame>
    <description>Overall response to treatment evaluated by study investigator and by professional caregiver caring for patient using the global assessment scale.&#xD;
A score of -4 indicates very marked worsening, 0 no change, and +4 very marked improvement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Dementia</condition>
  <condition>Paratonia</condition>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline injection up to 5 cc in arm with paratonia (one time injection)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Botulinum Toxin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Up to 300 U (5 cc) of Botulinum toxin diluted 2:1 (2 cc per 100 U of Botulinum toxin) (one time injection)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum Toxin</intervention_name>
    <arm_group_label>Botulinum Toxin</arm_group_label>
    <other_name>Xeomin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Severe cognitive impairment (complete dependency in all activities of daily living&#xD;
             (ADLs)&#xD;
&#xD;
          -  Diagnosis of Alzheimer's disease, vascular dementia,or frontotemporal dementia&#xD;
&#xD;
          -  Score&gt; 3 on the paratonic assessment instrument, with paratonic rigidity in an arm(s)&#xD;
             interfering in the provision of care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alternate etiologies for increased tone&#xD;
&#xD;
          -  Botulinum toxin 6 months preceding the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Galit Kleiner-Fisman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto, Baycrest</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistive Technology Clinic at Baycrest</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6A 2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Canadian study of health and aging: study methods and prevalence of dementia. CMAJ. 1994 Mar 15;150(6):899-913.</citation>
    <PMID>8131123</PMID>
  </reference>
  <reference>
    <citation>Matthews FE, Dening T; UK Medical Research Council Cognitive Function and Ageing Study. Prevalence of dementia in institutional care. Lancet. 2002 Jul 20;360(9328):225-6. doi: 10.1016/S0140-6736(02)09461-8.</citation>
    <PMID>12133659</PMID>
  </reference>
  <reference>
    <citation>Fox PJ, Kohatsu N, Max W, Arnsberger P. Estimating the costs of caring for people with Alzheimer disease in California: 2000-2040. J Public Health Policy. 2001;22(1):88-97.</citation>
    <PMID>11382092</PMID>
  </reference>
  <reference>
    <citation>Hobbelen JS, Koopmans RT, Verhey FR, Habraken KM, de Bie RA. Diagnosing paratonia in the demented elderly: reliability and validity of the Paratonia Assessment Instrument (PAI). Int Psychogeriatr. 2008 Aug;20(4):840-52. doi: 10.1017/S1041610207006424. Epub 2008 Jan 7.</citation>
    <PMID>18177542</PMID>
  </reference>
  <reference>
    <citation>Franssen EH, Kluger A, Torossian CL, Reisberg B. The neurologic syndrome of severe Alzheimer's disease. Relationship to functional decline. Arch Neurol. 1993 Oct;50(10):1029-39. doi: 10.1001/archneur.1993.00540100024010.</citation>
    <PMID>8215960</PMID>
  </reference>
  <reference>
    <citation>Hobbelen JS, Verhey FR, Bor JH, de Bie RA, Koopmans RT. Passive movement therapy in patients with moderate to severe paratonia; study protocol of a randomised clinical trial (ISRCTN43069940). BMC Geriatr. 2007 Dec 19;7:30. doi: 10.1186/1471-2318-7-30.</citation>
    <PMID>18093298</PMID>
  </reference>
  <reference>
    <citation>Souren LE, Franssen EH, Reisberg B. Neuromotor changes in Alzheimer's disease: implications for patient care. J Geriatr Psychiatry Neurol. 1997 Jul;10(3):93-8. doi: 10.1177/089198879701000301.</citation>
    <PMID>9322130</PMID>
  </reference>
  <reference>
    <citation>Kao I, Drachman DB, Price DL. Botulinum toxin: mechanism of presynaptic blockade. Science. 1976 Sep 24;193(4259):1256-8. doi: 10.1126/science.785600.</citation>
    <PMID>785600</PMID>
  </reference>
  <reference>
    <citation>Brashear A, Gordon MF, Elovic E, Kassicieh VD, Marciniak C, Do M, Lee CH, Jenkins S, Turkel C; Botox Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002 Aug 8;347(6):395-400. doi: 10.1056/NEJMoa011892.</citation>
    <PMID>12167681</PMID>
  </reference>
  <reference>
    <citation>Elovic EP, Brashear A, Kaelin D, Liu J, Millis SR, Barron R, Turkel C. Repeated treatments with botulinum toxin type a produce sustained decreases in the limitations associated with focal upper-limb poststroke spasticity for caregivers and patients. Arch Phys Med Rehabil. 2008 May;89(5):799-806. doi: 10.1016/j.apmr.2008.01.007.</citation>
    <PMID>18452724</PMID>
  </reference>
  <reference>
    <citation>Giovannelli M, Borriello G, Castri P, Prosperini L, Pozzilli C. Early physiotherapy after injection of botulinum toxin increases the beneficial effects on spasticity in patients with multiple sclerosis. Clin Rehabil. 2007 Apr;21(4):331-7. doi: 10.1177/0269215507072772.</citation>
    <PMID>17613573</PMID>
  </reference>
  <reference>
    <citation>Simpson DM, Gracies JM, Yablon SA, Barbano R, Brashear A; BoNT/TZD Study Team. Botulinum neurotoxin versus tizanidine in upper limb spasticity: a placebo-controlled study. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):380-5. doi: 10.1136/jnnp.2008.159657. Epub 2008 Oct 31.</citation>
    <PMID>18977811</PMID>
  </reference>
  <reference>
    <citation>Wells DL, Dawson P, Sidani S, Craig D, Pringle D. Effects of an abilities-focused program of morning care on residents who have dementia and on caregivers. J Am Geriatr Soc. 2000 Apr;48(4):442-9. doi: 10.1111/j.1532-5415.2000.tb04704.x.</citation>
    <PMID>10798473</PMID>
  </reference>
  <reference>
    <citation>Brin MF. Dosing, administration, and a treatment algorithm for use of botulinum toxin A for adult-onset spasticity. Spasticity Study Group. Muscle Nerve Suppl. 1997;6:S208-20. doi: 10.1002/(sici)1097-4598(1997)6+3.0.co;2-1.</citation>
    <PMID>9826992</PMID>
  </reference>
  <reference>
    <citation>Bhakta BB, Cozens JA, Chamberlain MA, Bamford JM. Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: a randomised double blind placebo controlled trial. J Neurol Neurosurg Psychiatry. 2000 Aug;69(2):217-21. doi: 10.1136/jnnp.69.2.217. Erratum In: J Neurol Neurosurg Psychiatry 2001 Jun;70(6):821.</citation>
    <PMID>10896696</PMID>
  </reference>
  <reference>
    <citation>Warden V, Hurley AC, Volicer L. Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. J Am Med Dir Assoc. 2003 Jan-Feb;4(1):9-15. doi: 10.1097/01.JAM.0000043422.31640.F7.</citation>
    <PMID>12807591</PMID>
  </reference>
  <reference>
    <citation>Naumann M, Yakovleff A, Durif F; BOTOX Cervical Dystonia Prospective Study Group. A randomized, double-masked, crossover comparison of the efficacy and safety of botulinum toxin type A produced from the original bulk toxin source and current bulk toxin source for the treatment of cervical dystonia. J Neurol. 2002 Jan;249(1):57-63. doi: 10.1007/pl00007848.</citation>
    <PMID>11954869</PMID>
  </reference>
  <reference>
    <citation>Albright AL, Barron WB, Fasick MP, Polinko P, Janosky J. Continuous intrathecal baclofen infusion for spasticity of cerebral origin. JAMA. 1993 Nov 24;270(20):2475-7.</citation>
    <PMID>8230625</PMID>
  </reference>
  <reference>
    <citation>Smetanin P, Kobak P, Briante C, Ahmad S. Rising Tide: The Impact of Dementia in Canada 2008 to 2038. RiskAnalytica; 2009.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>Dupre E. Debilite mentale and debilite motrice associees. Rev Neurol 1910;20:54-56.</citation>
  </reference>
  <reference>
    <citation>Delagi EF, Perotto A, Iazzetti J, Morrison D. Anatomic Guides for the Elecromyographer. In: Charles C.Thomas, ed., 2nd ed Springfield, 1980.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>Waltz CFSOL, Lenz ER. Measurement in Nursing Research, 2nd ed. Philadelphia: F.A. Davis, 1991.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assistive Technology Clinic, Canada</investigator_affiliation>
    <investigator_full_name>Dr. Galit Kleiner-Fisman</investigator_full_name>
    <investigator_title>Medical Director, Assistive Technology Clinic, Assistant Professor Department of Medicine, University of Toronto</investigator_title>
  </responsible_party>
  <keyword>Dementia</keyword>
  <keyword>Paratonia</keyword>
  <keyword>Caregiver Burden</keyword>
  <keyword>Botulinum toxin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02212119
org study id: NT-036
nct id: NCT02212119
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Impact on care-giver burden
time frame: 6 weeks for primary outcome, 32 weeks for entire study
description: 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").
measure: Visual Analogue Scale
time frame: 6 weeks for secondary outcome, 32 weeks for entire study
description: 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"
measure: Joint angle measurement
time frame: 6 weeks for secondary outcome, 32 weeks for entire study
description: Joint angle measurements were used reflecting range of motion.
Used as a surrogate measure for severity of paratonia
measure: Pain
time frame: 6 weeks for secondary outcome, 32 weeks for entire study
description: 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.
measure: Global Assessment
time frame: 6 weeks for secondary outcome, 32 weeks for entire study
description: 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.
arm group label: Saline
arm group type: Placebo Comparator
description: Saline injection up to 5 cc in arm with paratonia (one time injection)
arm group label: Botulinum Toxin
arm group type: Active Comparator
description: Up to 300 U (5 cc) of Botulinum toxin diluted 2:1 (2 cc per 100 U of Botulinum toxin) (one time injection)
intervention type: Drug
intervention name: Botulinum Toxin
arm group label: Botulinum Toxin
other name: Xeomin
intervention type: Drug
intervention name: Saline
arm group label: Saline
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Galit Kleiner-Fisman, MD
role: Principal Investigator
affiliation: University of Toronto, Baycrest
facility: 
country: Canada
citation: Canadian study of health and aging: study methods and prevalence of dementia. CMAJ. 1994 Mar 15;150(6):899-913.
PMID: 8131123
citation: Matthews FE, Dening T; UK Medical Research Council Cognitive Function and Ageing Study. Prevalence of dementia in institutional care. Lancet. 2002 Jul 20;360(9328):225-6. doi: 10.1016/S0140-6736(02)09461-8.
PMID: 12133659
citation: Fox PJ, Kohatsu N, Max W, Arnsberger P. Estimating the costs of caring for people with Alzheimer disease in California: 2000-2040. J Public Health Policy. 2001;22(1):88-97.
PMID: 11382092
citation: Hobbelen JS, Koopmans RT, Verhey FR, Habraken KM, de Bie RA. Diagnosing paratonia in the demented elderly: reliability and validity of the Paratonia Assessment Instrument (PAI). Int Psychogeriatr. 2008 Aug;20(4):840-52. doi: 10.1017/S1041610207006424. Epub 2008 Jan 7.
PMID: 18177542
citation: Franssen EH, Kluger A, Torossian CL, Reisberg B. The neurologic syndrome of severe Alzheimer's disease. Relationship to functional decline. Arch Neurol. 1993 Oct;50(10):1029-39. doi: 10.1001/archneur.1993.00540100024010.
PMID: 8215960
citation: Hobbelen JS, Verhey FR, Bor JH, de Bie RA, Koopmans RT. Passive movement therapy in patients with moderate to severe paratonia; study protocol of a randomised clinical trial (ISRCTN43069940). BMC Geriatr. 2007 Dec 19;7:30. doi: 10.1186/1471-2318-7-30.
PMID: 18093298
citation: Souren LE, Franssen EH, Reisberg B. Neuromotor changes in Alzheimer's disease: implications for patient care. J Geriatr Psychiatry Neurol. 1997 Jul;10(3):93-8. doi: 10.1177/089198879701000301.
PMID: 9322130
citation: Kao I, Drachman DB, Price DL. Botulinum toxin: mechanism of presynaptic blockade. Science. 1976 Sep 24;193(4259):1256-8. doi: 10.1126/science.785600.
PMID: 785600
citation: Brashear A, Gordon MF, Elovic E, Kassicieh VD, Marciniak C, Do M, Lee CH, Jenkins S, Turkel C; Botox Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002 Aug 8;347(6):395-400. doi: 10.1056/NEJMoa011892.
PMID: 12167681
citation: Elovic EP, Brashear A, Kaelin D, Liu J, Millis SR, Barron R, Turkel C. Repeated treatments with botulinum toxin type a produce sustained decreases in the limitations associated with focal upper-limb poststroke spasticity for caregivers and patients. Arch Phys Med Rehabil. 2008 May;89(5):799-806. doi: 10.1016/j.apmr.2008.01.007.
PMID: 18452724
citation: Giovannelli M, Borriello G, Castri P, Prosperini L, Pozzilli C. Early physiotherapy after injection of botulinum toxin increases the beneficial effects on spasticity in patients with multiple sclerosis. Clin Rehabil. 2007 Apr;21(4):331-7. doi: 10.1177/0269215507072772.
PMID: 17613573
citation: Simpson DM, Gracies JM, Yablon SA, Barbano R, Brashear A; BoNT/TZD Study Team. Botulinum neurotoxin versus tizanidine in upper limb spasticity: a placebo-controlled study. J Neurol Neurosurg Psychiatry. 2009 Apr;80(4):380-5. doi: 10.1136/jnnp.2008.159657. Epub 2008 Oct 31.
PMID: 18977811
citation: Wells DL, Dawson P, Sidani S, Craig D, Pringle D. Effects of an abilities-focused program of morning care on residents who have dementia and on caregivers. J Am Geriatr Soc. 2000 Apr;48(4):442-9. doi: 10.1111/j.1532-5415.2000.tb04704.x.
PMID: 10798473
citation: Brin MF. Dosing, administration, and a treatment algorithm for use of botulinum toxin A for adult-onset spasticity. Spasticity Study Group. Muscle Nerve Suppl. 1997;6:S208-20. doi: 10.1002/(sici)1097-4598(1997)6+3.0.co;2-1.
PMID: 9826992
citation: Bhakta BB, Cozens JA, Chamberlain MA, Bamford JM. Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: a randomised double blind placebo controlled trial. J Neurol Neurosurg Psychiatry. 2000 Aug;69(2):217-21. doi: 10.1136/jnnp.69.2.217. Erratum In: J Neurol Neurosurg Psychiatry 2001 Jun;70(6):821.
PMID: 10896696
citation: Warden V, Hurley AC, Volicer L. Development and psychometric evaluation of the Pain Assessment in Advanced Dementia (PAINAD) scale. J Am Med Dir Assoc. 2003 Jan-Feb;4(1):9-15. doi: 10.1097/01.JAM.0000043422.31640.F7.
PMID: 12807591
citation: Naumann M, Yakovleff A, Durif F; BOTOX Cervical Dystonia Prospective Study Group. A randomized, double-masked, crossover comparison of the efficacy and safety of botulinum toxin type A produced from the original bulk toxin source and current bulk toxin source for the treatment of cervical dystonia. J Neurol. 2002 Jan;249(1):57-63. doi: 10.1007/pl00007848.
PMID: 11954869
citation: Albright AL, Barron WB, Fasick MP, Polinko P, Janosky J. Continuous intrathecal baclofen infusion for spasticity of cerebral origin. JAMA. 1993 Nov 24;270(20):2475-7.
PMID: 8230625
citation: Smetanin P, Kobak P, Briante C, Ahmad S. Rising Tide: The Impact of Dementia in Canada 2008 to 2038. RiskAnalytica; 2009.
citation: 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.
citation: Dupre E. Debilite mentale and debilite motrice associees. Rev Neurol 1910;20:54-56.
citation: Delagi EF, Perotto A, Iazzetti J, Morrison D. Anatomic Guides for the Elecromyographer. In: Charles C.Thomas, ed., 2nd ed Springfield, 1980.
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responsible party type: Principal Investigator
investigator affiliation: Assistive Technology Clinic, Canada
investigator full name: Dr. Galit Kleiner-Fisman
investigator title: Medical Director, Assistive Technology Clinic, Assistant Professor Department of Medicine, University of Toronto
mesh term: Dementia
mesh term: Botulinum Toxins