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DementiaPhase 2NCT02212119

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

A Phase 2 study testing Botulinum Toxin and Saline in people with Dementia and Paratonia, run by Assistive Technology Clinic, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Dementia, Paratonia
What is being tested?
Botulinum Toxin and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteCanada
Study dates
Dec 2010to Jan 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Alternate etiologies for increased tone
  • Botulinum toxin 6 months preceding the study

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Assistive Technology Clinic at Baycrest

    Toronto, Ontario, M6A 2E1

Other trials in Canada

About this study

Official title: 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.

Conditions
Dementia, Paratonia
Being tested
Botulinum Toxin, Saline
Keywords
Dementia, Paratonia, Caregiver Burden, Botulinum toxin
Medical subject headings
Dementia, Muscle Rigidity, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum ToxinDrug

    Also called Xeomin

  • SalineDrug

Study groups in NCT02212119
Study groupRoleWhat they receive
SalinePlacebo comparatorSaline injection up to 5 cc in arm with paratonia (one time injection)
Receives: Drug: Saline
Botulinum ToxinActive comparatorUp to 300 U (5 cc) of Botulinum toxin diluted 2:1 (2 cc per 100 U of Botulinum toxin) (one time injection)
Receives: Drug: Botulinum Toxin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact on care-giver burden

    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").

    Measured: 6 weeks for primary outcome, 32 weeks for entire study

Secondary outcomes (4)

  1. Visual Analogue Scale

    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"

    Measured: 6 weeks for secondary outcome, 32 weeks for entire study

  2. Joint angle measurement

    Joint angle measurements were used reflecting range of motion.

    Used as a surrogate measure for severity of paratonia

    Measured: 6 weeks for secondary outcome, 32 weeks for entire study

  3. Pain

    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.

    Measured: 6 weeks for secondary outcome, 32 weeks for entire study

  4. Global Assessment

    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.

    Measured: 6 weeks for secondary outcome, 32 weeks for entire study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2014 (estimated)
  2. Study startDec 2010
  3. Primary completionFeb 2013
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02212119
Sponsor's protocol ID
NT-036
Status last verified
Aug 2014
First submitted
6 Aug 2014
Last updated
8 Aug 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Canadian study of health and aging: study methods and prevalence of dementia. CMAJ. 1994 Mar 15;150(6):899-913.

    PubMed 8131123

  • 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.

    PubMed 12133659

  • 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.

    PubMed 11382092

  • 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.

    PubMed 18177542

  • 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.

    PubMed 8215960

  • 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.

    PubMed 18093298

  • 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.

    PubMed 9322130

  • 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.

    PubMed 785600

  • 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.

    PubMed 12167681

  • 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.

    PubMed 18452724

  • 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.

    PubMed 17613573

  • 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.

    PubMed 18977811

  • 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.

    PubMed 10798473

  • 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.

    PubMed 9826992

  • 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.

    PubMed 10896696

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Botulinum Toxin and Saline in people with Dementia and Paratonia, run by Assistive Technology Clinic, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact on care-giver burden (time frame: 6 weeks for primary outcome, 32 weeks for entire study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02212119, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.

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