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

Assistive Technology Clinic, Canada

Status and phase: Completed; Phase 2

Conditions: Paratonia; Dementia

Treatments: Drug: Saline; Drug: Botulinum Toxin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02212119

NT-036

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

Saline injection up to 5 cc in arm with paratonia (one time injection)

Treatment:

Drug: Saline

Botulinum Toxin

Active Comparator group

Description:

Up to 300 U (5 cc) of Botulinum toxin diluted 2:1 (2 cc per 100 U of Botulinum toxin) (one time injection)

Treatment:

Drug: Botulinum Toxin