Paratonia in Advanced Dementia: Deconstructing Scientific, Regulatory, and Health System Barriers to Botulinum Toxin A (BoNT-A) Treatment of Involuntary Muscle Resistance.

Paratonia, a movement disorder characterized by involuntary muscle resistance, affects nearly all people with advanced dementia and contributes to caregiver burden, hygiene complications, pressure injuries, and pain. With Alzheimer's disease and related dementias affecting 7.2 million Americans and projected to reach nearly 14 million by 2060, the clinical impact of paratonia will expand proportionally. Because the involuntary muscle resistance of paratonia is frequently misinterpreted as deliberate noncompliance, individuals may receive inappropriate pharmacologic management rather than targeted treatment of the underlying movement disorder. No treatments are currently approved specifically for paratonia-induced muscle postures. Passive motion therapy, which the Centers for Medicare & Medicaid Services quality standards promote for contracture prevention in nursing homes, showed no benefit for paratonia in a randomized controlled trial of individuals with advanced dementia. Furthermore, passive movement therapy may paradoxically reinforce abnormal motor patterns by triggering increased involuntary resistance, the defining feature of paratonia. Botulinum toxin A, in therapeutic use since 1989, with Food and Drug Administration approval, is an established treatment for post-stroke spasticity and cervical dystonia. These conditions, like paratonia, arise from distinct central nervous system pathologies but share a peripheral manifestation of involuntary sustained muscle contraction. Preliminary clinical evidence suggests potential safety and efficacy for paratonia-induced muscle postures. Despite the therapeutic rationale and preliminary evidence for safety and efficacy, pharmaceutical companies have not pursued regulatory approval for the paratonia indication. This article examines barriers to clinical development, including scientific uncertainties, knowledge gaps, infrastructure limitations, therapeutic nihilism, policy barriers, and pharmaceutical industry considerations. We propose coordinated stakeholder action across research, education, policy, and regulatory domains to establish pathways toward further research and, if warranted, clinical implementation.