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Completed

NCT Number: NCT02212119

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

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.

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Key information

Conditions

Dementia Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Mental Disorders Muscle Hypertonia Muscle Rigidity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Neuromuscular Manifestations Paratonia Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress, Psychological

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Assistive Technology Clinic at Baycrest

Toronto, Ontario, M6A 2E1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin

Drug

Other names: Xeomin

Saline

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Assistive Technology Clinic, Canada

Other

Collaborators

  • Baycrest
  • Merz Pharmaceuticals GmbH

Registry information

Official study title

A Randomized, Placebo Controlled Trial of Botulinum Toxin for Paratonic Rigidity in People With Advanced Cognitive Impairment

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Aug 8, 2014
Registry last updated
Aug 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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