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

August 7, 2014 updated by: Dr. Galit Kleiner-Fisman, Assistive Technology Clinic, Canada

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6A 2E1
        • Assistive Technology Clinic at Baycrest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • Xeomin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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").
6 weeks for primary outcome, 32 weeks for entire study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
6 weeks for secondary outcome, 32 weeks for entire study
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
6 weeks for secondary outcome, 32 weeks for entire study
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.
6 weeks for secondary outcome, 32 weeks for entire study
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.
6 weeks for secondary outcome, 32 weeks for entire study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistive Technology Clinic, Canada

Collaborators

Merz Pharmaceuticals GmbH
Baycrest

Investigators

  • Principal Investigator: Galit Kleiner-Fisman, MD, University of Toronto, Baycrest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 7, 2014

First Posted (Estimate)

August 8, 2014

Study Record Updates

Last Update Posted (Estimate)

August 8, 2014

Last Update Submitted That Met QC Criteria

August 7, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NT-036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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